Clinical Data Manager Jobs

Job Title: Clinical Data Manager Company: MedFocus Location: Scotch Plains, NJ Description: .ugDivBody_hj .ugFrame_hj .ugColWrap_hj .ugHeader_hj .ugHeadBot_hj .ugHeadBot_hj a:link .ugHeadBot_hj a:visited .ugHeadBot_hj a:hover, active .ugSeeLink_hj .ugLeftWrap_hj .ugLeftCol_hj .ugJobTitleLeft_hj .ugJobTitleLeft1_hj .ugLTable_hj .ugLHead_hj .ugLText_hj .ugMap_hj .ugMapplace_hj .ugRightWrap_hj .ugRightCol_hj .ugROver_hj .ugLeftLinks_hj a:link .ugBold_hj .ugRTitle1_hj .ugRtext_hj .ugFooter_hj .ugBanner_hj See all jobs at this company Job overview Company:  MedFocus Job Id:  Register to View Job Title:  Clinical Data Manager Location:  Scotch Plains, NJ Job Category:  Pharmaceutical/Biotech Position Type:  Full-Time, Contract Education:  Bachelor of Science Experience:  2-5 Years Experience Company overview Since 1993, MedFocus has succeeded in meeting the contract staffing needs of our consultants and clients faster and more effectively than our competition through "specialized" recruiting exclusively in the pharmaceutical arena. By staying focused, MedFocus has become the firm of choice for both client companies and our consultant job seekers. MedFocus is headquartered in Chicago, IL and has offices in Philadelphia, PA and San Francisco, CA. Learn More about MedFocus Company Website About Us Clinical Data Manager Job Description CLINICAL DATA MANAGERCOMPANY INFO:MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.Our client embraces research and science - bringing innovative ideas, products and services to advance the health and well-being of people and is seeking to add a Clinical Data Manager to their team.RESPONSIBILITIES:• Direct and supervise all aspects of the data management process, ensuring compliance with FDA regulations related to data management. Provide guidance to Clinical Database Administrator. • Train data entry personnel and Clinical Research Associates (CRA) in procedures relative to data management. • Ensure compliance with department procedures. Provide input into Case Report Forms (CRF) design and approve CRFs for production use. • Oversee the design of Oracle Clinical databases, including maintenance of the global library; validate database design; program edit-check procedures and validate new edit-check processes; perform and direct data entry processes; run batch validation and track DCFs through data cleaning; code adverse events and concomitant medications using standard coding dictionaries (MedDRA, WHO Drug); maintain coding dictionaries; lock/freeze databases; extract into SAS datasets for analysis. • Administer Oracle Thesaurus Management System repository. • Set up new studies in the Clinical Research Management System (CRMS) clinical trial management system, and maintain the CRMS database. • Train new CRAs in the use of CRMS. QUALIFICATIONS:• 5 years of experience. • 1-2 years Electronic Data Capture (eDC) RAVE build experience – Able to build studies in Medidata RAVE • 2-3 years Data Management experienceMedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.

Job Title: *Assistant Clinical Data Manager/Data Team Lead- Wilmington, DE Company: Quintiles Location: Wilmington, DE Description: Home based Opportunities Available! Statewide!  The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else in the world.  Become involved in work that improves the quality of life for people around the globe.  Let your career soar! We are seeking an enthusiastic Assistant Clinical Data Manager/Data Team Lead to join our team!   Purpose:  Provide comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs. Provide leadership role as a Data Team Lead (DTL) or in a leadership role in a specific DM task (e.g. lead of a task on a megatrial, coder, database designer for technologies that don’t require extensive programming expertise). Responsibilities: Serve as Data Team Lead (DTL) on multiple global studies.Provide leadership to DM team.Manage DM customer relationship for DM project team including active participation in DM customer negotiation ontimeline, budgetary and other issues (with guidance).Provide marketing capabilities presentations and business development presentations.Serve as Data Team Lead for one or two global studies with fewer than 20 operations staff(excludes DE), or serve in a leadership role to a specific DM Task.With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadershipand technical expertise to Operations team.Manage delivery of projects through full data management process life-cycle.With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justifyout-of-scope.Provide input for negotiations with customer.Provide comprehensive data management expertise (including all operations tasks and DMP generation).Perform database designer activities for technologies not requiring extensive programming.Perform comprehensive quality control procedures.Independently bring project solutions to the CDM team.Solves issues through using the global issue escalation/communication plan.Consult with Standards Group for process issues; communicate ideas for process improvement.Assist in developing and implementing new technology.Understand and comply with core operating procedures and working instructions.Meet objectives as assigned.Develop and maintain good communications and working relationships with CDM team.Interact with CDM team members to negotiate timelines and responsibilities.Bachelor’s degree in clinical, biological or mathematical sciences, nursing degree or related field, with a minimum of 3 years experience in a clinical data management role, specifically in a CRO, pharmaceutical or biotech environment or the equivalent of education, training or experience.Candidates must have prior work experience in a lead role, managing assigned projects on all levels, acting as the project lead. Candiate must have a thorough knowledge of the clinical trial data management process.Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology.Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III).Comprehensive understanding of clinical drug development process.Excellent organizational, communication, and data management skills (detail oriented).Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Job Title: Clinical Data Manager - Telecommute Company: Alpha Professional Resources Location: Thousand Oaks, CA Description: Clinical Data Manager * TO(Telecommute Option)To lead and coordinate Clinical Data Management (CDM) activities for assigned studies. This is a regional role based in the US or UK, which may entail some global responsibilities. RESPONSIBLE FOR: * Delivering of data for assigned studies * Contributing to clinical study planning * Ensuring that data quality meets expectations * Ensuring that CDM deliverables are to agreed timelines * Communicating within assigned study teams re: CDM activities * Providing CDM documents for assigned studies as defined by CDM processes * Ensuring that Clinical Data Management (CDM) procedures and processes meet business requirements and are adhered to KEY ACTIVITIES INCLUDE: * Training and mentoring * Development and review of processes, policies, SOPs and associated documents for CDM * Facilitation of inter / intra departmental communication such as debriefs / lessons learned BASIC QUALIFICATIONS : (Bachelors degree in life science, computer science, business administration or related discipline, with 3 or more years work experience in life sciences or a medical related field) OR (High school diploma, with 7 or more years work experience in life sciences or a medical related field) PREFERRED QUALIFICATIONS: * 4 or more years work experience in data management in the Pharmaceutical or Biotech arena * 2 or more years experience in managing study level projects KNOWLEDGE * Good Clinical Practice * Drug Development and Clinical Trials Processes * Data Management Processes * Clinical Trial Databases and Applications * Ability to understand technical, scientific and medical information * Good organizational and planning skills

Job Title: *Senior Clinical Data Manager, Global Drug Development Company: SRA International Location: Durham, NC Description: Daily Responsibilities Are you interested in playing a key role in your department? Are you looking for a family friendly CRO that offers a manageable workload and a balance of work and life? Do you like to work on interesting projects where you can play a diverse and key role on the program? Then we are the place for you! Global Drug Development is one of four business units under the Global Health Sector of SRA International. This business unit works as a CRO to assist both pharmaceutical and biotechnology clients in all areas of drug development, including: pre-clinical product development consulting, Phase I - IV clinical trials (including clinical monitoring, trials management, data management, statistics and SAS programming); regulatory affairs and strategic drug development consulting; quality assurance; medical writing; pharmacovigilance; and program management. Therapeutic areas of expertise include: HIV/AIDS, oncology, diabetes, CNS, sexual dysfunction and vaccines.We are currently searching for a Senior Clinical Data Manager (SCDM) to oversee, lead, and perform data management activities in support of clinical studies. Senior Clinical Data Managers oversee a team of clinical data analysts and other data support staff to take a project from study start up, through maintenance, to close out. Senior Clinical Data Managers liaise not only with the client / sponsor company; but also with other internal departments such as statistics, Medical Writing, Regulatory, and Clinical.Key responsibilities include: Managing multiple studies of various sizes from study set-up through maintenance and closeout, while still maintaining a manageable workload. Our clinical programs include both Electronic Data Capture (EDC) and paper-based studies. Leads and manages the project management activities for the lifecycle of the study, including management of timelines, budgets, staff / resourcing, project scope, reports and communication Coordinates and conducts setup activities, such as CRF design, database structure design, CRF annotation, project document creation and/or approval, data entry screen design and testing, validation check creation, testing and approval Oversees database set up with the Clinical Programming team Oversees and conducts the review of medical coding for validity and completeness Conducts internal and external team meetings, including monthly project review meetings, representing Clinical Data Management Represents the Data Management department by contributing to client proposals Leads and participates in presentations to clients, sites, and cross-functional groups; including presentations at proposal defense and capability meetings Senior Clinical Data Managers may also supervise and/or mentor, either directly or indirectly, the activities of Clinical Data Managers, Sr. Clinical Data Analysts and Clinical Data Analysts Required: Years of experience (min) 3-5 Required: Degree Bachelors Required: Skills Requires a BA degree and 3 - 5 years experience working in the field of clinical trials and data management. Requires previous experience leading a data management project team for Ph I - IV clinical trials Strongly prefer at least 1 year experience utilizing Electronic Data Capture (EDC) either in an oversight or hands on role. Requires experience utilizing a clinical database (Oracle Clinical preferred but not required). Requires experience with MS Word and Excel. Strongly prefer experience presenting to clients at bid defenses, study kick off meetings, etc. Excellent analytical, organizational and problem-solving abilities, and ability to prioritize multiple tasks Excellent delegation abilities Well-developed leadership capabilities and interpersonal skills Highly effective communication skills, both written and verbal Excellent attention to detail and initiative Additional preferred skills may include any of the following: CRF design, MS Project, programming skills (SAS, PL/SQL), analytical capabilities, medical coding (adverse events, medical histories and medical therapies). Desired: Degree Bachelors To learn more about SRA International, go to www.sra.com SRA International is an Equal Opportunity Employer.

Job Title: Senior Clinical Data Manager Company: Genentech Location: South San Francisco, CA Description: Senior Clinical Data ManagerLocation of Position: South San Francisco, CASummary:Clinical Data Management (CDM) resides within the Data Management and Programming Function in the Department of Biometrics, Health Outcomes and Payer Support (BHOPS) in US Medical Affairs.Members of the CDM group are allocated to work in one of three Disease Biology Areas (Autoimmune, Oncology or Metabolism) and report to the CDM Team Leader.Individual Data Managers (DM) work as members of the Study Management Team for a sponsored clinical trial (or disease Registry) to oversee the completeness, accuracy and internal consistency of the data for the trial, or manage this work when it is conducted by an external vendor. Additionally, DMs may be required to generate data tabulations, profiles and listings to support Medical and Clinical colleagues with the monitoring and clinical review of the data, or status reports, to inform the SMT of the study progress.Members of the CDM group use a variety of tools to assist them with their responsibilities, including clinical data browsers (such as Hyperion Brio and Oracle Discover), SAS, Oracle Clinical and Electronic Data Capture (EDC) Systems, such as Phase Forward Inform or Medidata Rave.Responsibilities:As an integral member of the SMT, the DM provides input to the development of the Study protocol. Additionally, the DM is responsible for keeping the SMT members fully and promptly updated on the status of the data flow and the data quality throughout the lifecycle of the clinical trial/disease Registry.Through a detailed working knowledge of applicable industry guidelines (such as GCP) and Genentech SOPs, the DM leads the creation of the Clinical Record Form (CRF/e-CRF) and provides oversight for the user testing of the clinical database which is created from the CRF.Via key study documents (such as the Data Management Plan, Data Validation Specification and the Data Review Plan) the DM is responsible for the completeness, accuracy and the internal consistency of all of the clinical data collected in the clinical trial or disease Registry. This responsibility extends to the collection of any laboratory safety data (including central laboratories) or data from ancillary data sources (such as academic labs, ECGs, pK data etc.) The DM ensures that the patient data are clean and complete in preparation for any agreed Reporting Event (such as Dry-Run, Interim Analysis, Final Database Lock etc).The DM is responsible for ensuring all coded items in the study are promptly and consistently coded.The DM routinely attends investigator meetings and may be required to prepare data presentations or Powerpoint presentations for such meetings.The DM works closely with the Medical Director and Drug Safety, to ensure there is ongoing Medical Review of the clinical data.At the end of the trial, the DM is responsible for the efficient locking of the data in the study/Registry, finalizing the applicable documentation in accordance with relevant SOPs and overseeing the archiving of documentation and clinical data.Requirements:* Proven experience in the management of consultants and/or staff at an external vendor is essential.* Proficient in the use of database management systems (such as Oracle Clinical, ClinTrial, Medidata Rave or Phase Forward INFORM.* Proficiency in the use of clinical data browsers (such as Hyperion Brio, Oracle Discover) essential* Knowledge and familiarity with database theory, specifically relational database concepts.* Good interpersonal skills. Good verbal and written communication skills.* Experience with desktop tools. Ability to work on multiple tasks simultaneously and meet project deadlines.* Demonstrated ability to interact confidently with members of other functional areas in clinical teams.* Thorough understanding of regulatory guidelines (such as ICH guidelines E6) that affect clinical deliverables.* Thorough understanding of applicable Roche / Genentech SOP* Competence in SAS Programming Language will be a positive advantage.* Thorough understanding of the clinical trials process. Extensive previous experience of working in a marketing environment with data from phase IV clinical trials is an advantage.* Working knowledge of CDISC SDTM standard is a positive advantage.* Participation in a regulatory filing, such as in the development of an e-submission or CTD will be a plus.* Experience interacting with others for defining and implementing data listings / patient profiles* Experience in working in teams and communicating one-on-one and with groups.Qualifications:A minimum of 5 years of clinical data management experience in a pharmaceutical or biotechnology company or clinical research organization (CRO) essential, with a BS or higher in a bio-medical discipline (eg Biological Sciences, pharmacology etc).DIVISION: Development - Medical AffairsREQUISITION NUMBER: 0 Register to View REQUIREMENTS - QUALIFICATIONS: Senior Clinical Data Manager See Information AboveGenentech

Job Title: *Assistant Clinical Data Manager/Data Team Lead- Philadelphia, PA Company: Quintiles Location: Philadelphia, PA Description: Home based Opportunities Available! Statewide!  The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else in the world.  Become involved in work that improves the quality of life for people around the globe.  Let your career soar! We are seeking an enthusiastic Assistant Clinical Data Manager/Data Team Lead to join our team!   Purpose:  Provide comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs. Provide leadership role as a Data Team Lead (DTL) or in a leadership role in a specific DM task (e.g. lead of a task on a megatrial, coder, database designer for technologies that don’t require extensive programming expertise). Responsibilities: Serve as Data Team Lead (DTL) on multiple global studies.Provide leadership to DM team.Manage DM customer relationship for DM project team including active participation in DM customer negotiation ontimeline, budgetary and other issues (with guidance).Provide marketing capabilities presentations and business development presentations.Serve as Data Team Lead for one or two global studies with fewer than 20 operations staff(excludes DE), or serve in a leadership role to a specific DM Task.With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadershipand technical expertise to Operations team.Manage delivery of projects through full data management process life-cycle.With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justifyout-of-scope.Provide input for negotiations with customer.Provide comprehensive data management expertise (including all operations tasks and DMP generation).Perform database designer activities for technologies not requiring extensive programming.Perform comprehensive quality control procedures.Independently bring project solutions to the CDM team.Solves issues through using the global issue escalation/communication plan.Consult with Standards Group for process issues; communicate ideas for process improvement.Assist in developing and implementing new technology.Understand and comply with core operating procedures and working instructions.Meet objectives as assigned.Develop and maintain good communications and working relationships with CDM team.Interact with CDM team members to negotiate timelines and responsibilities.Bachelor’s degree in clinical, biological or mathematical sciences, nursing degree or related field, with a minimum of 3 years experience in a clinical data management role, specifically in a CRO, pharmaceutical or biotech environment or the equivalent of education, training or experience.Candidates must have prior work experience in a lead role, managing assigned projects on all levels, acting as the project lead. Candiate must have a thorough knowledge of the clinical trial data management process.Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology.Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III).Comprehensive understanding of clinical drug development process.Excellent organizational, communication, and data management skills (detail oriented).Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Job Title: *Assistant Clinical Data Manager/Data Team Lead- Indianapolis, IN Company: Quintiles Location: Indianapolis, IN Description: The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else in the world.  Become involved in work that improves the quality of life for people around the globe.  Let your career soar! We are seeking an enthusiastic Assistant Clinical Data Manager/Data Team Lead to join our team!   Home based Opportunities Available!  Purpose:  Provide comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs. Provide leadership role as a Data Team Lead (DTL) or in a leadership role in a specific DM task (e.g. lead of a task on a megatrial, coder, database designer for technologies that don’t require extensive programming expertise). Responsibilities: Serve as Data Team Lead (DTL) on multiple global studies.Provide leadership to DM team.Manage DM customer relationship for DM project team including active participation in DM customer negotiation ontimeline, budgetary and other issues (with guidance).Provide marketing capabilities presentations and business development presentations.Serve as Data Team Lead for one or two global studies with fewer than 20 operations staff(excludes DE), or serve in a leadership role to a specific DM Task.With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadershipand technical expertise to Operations team.Manage delivery of projects through full data management process life-cycle.With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justifyout-of-scope.Provide input for negotiations with customer.Provide comprehensive data management expertise (including all operations tasks and DMP generation).Perform database designer activities for technologies not requiring extensive programming.Perform comprehensive quality control procedures.Independently bring project solutions to the CDM team.Solves issues through using the global issue escalation/communication plan.Consult with Standards Group for process issues; communicate ideas for process improvement.Assist in developing and implementing new technology.Understand and comply with core operating procedures and working instructions.Meet objectives as assigned.Develop and maintain good communications and working relationships with CDM team.Interact with CDM team members to negotiate timelines and responsibilities.Bachelor’s degree in clinical, biological or mathematical sciences, nursing degree or related field, with a minimum of 3 years experience in a clinical data management role, specifically in a CRO, pharmaceutical or biotech environment or the equivalent of education, training or experience.Candidates must have prior work experience in a lead role, managing assigned projects on all levels, acting as the project lead. Candiate must have a thorough knowledge of the clinical trial data management process.Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology.Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III).Comprehensive understanding of clinical drug development process.Excellent organizational, communication, and data management skills (detail oriented).Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Job Title: *Assistant Clinical Data Manager/Data Team Lead- Overland Park, KS Company: Quintiles Location: Overland Park, KS Description: The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else in the world.  Become involved in work that improves the quality of life for people around the globe.  Let your career soar! We are seeking an enthusiastic Assistant Clinical Data Manager/Data Team Lead to join our team!   Purpose:   Provide comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs. Provide leadership role as a Data Team Lead (DTL) or in a leadership role in a specific DM task (e.g. lead of a task on a megatrial, coder, database designer for technologies that don't require extensive programming expertise).   Responsibilities:   Serve as Data Team Lead (DTL) on multiple global studies. Provide leadership to DM team. Manage DM customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues (with guidance). Provide marketing capabilities presentations and business development presentations. Serve as Data Team Lead for one or two global studies with fewer than 20 operations staff (excludes DE), or serve in a leadership role to a specific DM Task. With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership and technical expertise to Operations team. Manage delivery of projects through full data management process life-cycle. With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify out-of-scope. Provide input for negotiations with customer. Provide comprehensive data management expertise (including all operations tasks and DMP generation). Perform database designer activities for technologies not requiring extensive programming. Perform comprehensive quality control procedures. Independently bring project solutions to the CDM team. Solves issues through using the global issue escalation/communication plan. Consult with Standards Group for process issues; communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Interact with CDM team members to negotiate timelines and responsibilities. Bachelor's degree in clinical, biological or mathematical sciences, nursing degree or related field, with a minimum of 3 years experience in a clinical data management role, specifically in a CRO, pharmaceutical or biotech environment or the equivalent of education, training or experience. Candidates must have prior work experience in a lead role, managing assigned projects on all levels, acting as the project lead. Candiate must have a thorough knowledge of the clinical trial data management process. Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology.Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III).Comprehensive understanding of clinical drug development process. Excellent organizational, communication, and data management skills (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Job Title: *Assistant Clinical Data Manager/Data Team Lead- King of Prussia, PA Company: Quintiles Location: King of Prussia, PA Description: Home based Opportunities Available! Statewide!     The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else in the world.  Become involved in work that improves the quality of life for people around the globe.  Let your career soar! We are seeking an enthusiastic Assistant Clinical Data Manager/Data Team Lead to join our team!    Purpose:   Provide comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs. Provide leadership role as a Data Team Lead (DTL) or in a leadership role in a specific DM task (e.g. lead of a task on a megatrial, coder, database designer for technologies that don't require extensive programming expertise).   Responsibilities:   Serve as Data Team Lead (DTL) on multiple global studies. Provide leadership to DM team. Manage DM customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues (with guidance). Provide marketing capabilities presentations and business development presentations. Serve as Data Team Lead for one or two global studies with fewer than 20 operations staff (excludes DE), or serve in a leadership role to a specific DM Task. With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership and technical expertise to Operations team. Manage delivery of projects through full data management process life-cycle. With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify out-of-scope. Provide input for negotiations with customer. Provide comprehensive data management expertise (including all operations tasks and DMP generation). Perform database designer activities for technologies not requiring extensive programming. Perform comprehensive quality control procedures. Independently bring project solutions to the CDM team. Solves issues through using the global issue escalation/communication plan. Consult with Standards Group for process issues; communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Interact with CDM team members to negotiate timelines and responsibilities. Bachelor's degree in clinical, biological or mathematical sciences, nursing degree or related field, with a minimum of 3 years experience in a clinical data management role, specifically in a CRO, pharmaceutical or biotech environment or the equivalent of education, training or experience. Candidates must have prior work experience in a lead role, managing assigned projects on all levels, acting as the project lead. Candiate must have a thorough knowledge of the clinical trial data management process. Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology.Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III).Comprehensive understanding of clinical drug development process. Excellent organizational, communication, and data management skills (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Job Title: Clinical Data Manager Company: Alpha Professional Resources Location: South San Francisco, CA Description: Clinical Data Manager - SFTo assist in Clinical Data Management (CDM) activities for assigned studies. RESPONSIBLE FOR: * Delivering of data for assigned studies * Ensuring that data quality meets expectations * Ensuring that CDM deliverables are to agreed timelines * Communicating within assigned study teams re: CDM activities * Providing CDM documents for assigned studies as defined by CDM processes * Ensuring that Clinical Data Management (CDM) procedures and processes meet business requirements and are adhered to BASIC QUALIFICATIONS : (Bachelors degree in life science, computer science, business administration or related discipline, with 3 or more years work experience in life sciences or a medical related field) OR (High school diploma, with 7 or more years work experience in life sciences or a medical related field) PREFERRED QUALIFICATIONS: * 4 or more years work experience in data management in the Pharmaceutical or Biotech arena * 2 or more years experience in managing study level projects KNOWLEDGE * Good Clinical Practice * Drug Development and Clinical Trials Processes * Data Management Processes * Clinical Trial Databases and Applications * Ability to understand technical, scientific and medical information * Good organizational and planning skills ADDITIONAL: EDC experience (Medidata Rave a plus); self starter, motivated; ability to work independently and in virtual teams; solid communication skills Reply to: Register to View third party