Clinical Research Manager Jobs

Job Title: Clinical Research Coordinator (LVN or B.S. Graduate Health/Biology) Company: Company Confidential Location: Pleasant Hill, CA Description: Supports clinical trials by collecting, screening, entering, and reporting information gathered. Duties: * Collects information by conducting pre-study visits; visiting study sites; administering and gathering questionnaires; conducting interviews and data queries; registering study participants; retrieving regulatory documents; conducting literature reviews. * Screens information by verifying legibility and accuracy, and adherence to protocols; maintaining tracking database. * Monitors information by maintaining tracking database. * Prepares monitoring reports by assembling, organizing, and summarizing status data; confirming Case Report Form (CRF) reporting. * Protects organization's value by keeping research information confidential; monitoring good clinical practices. * Maintains safe study environment by reporting Serious Adverse Events (SAE); following organization standards and legal regulations. * Maintains supplies inventory by checking stock; anticipating needs; placing and expediting requests; verifying receipt. * Updates job knowledge by participating in educational opportunities; reading technical publications. * Accomplishes research and organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments. Skills/Qualifications: Reporting Skills, Bioinformatics, GCP, Clinical Research, Analyzing Information, Confidentiality, Teamwork, Excellent Verbal & WrittenCommunication Skills, Problem Solving, PC Proficiency, Conceptual Skills, Exceptional Attention to Detail & Follow-Through, "Good Customer Service"- Pleasant Manner, and Reliable Transportation (local travel required).

Job Title: Senior Clinical Trial Manager Company: Genentech, Inc. Location: South San Francisco, CA Description: ABOUT US For more than 30 years, Genentech has been at the forefront of the Biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the world's leading biotech companies, with multiple therapies on the market for cancer and other serious medical conditions. Our employees cite the chance to make a difference in the lives of patients as the number one reason they enjoy working at Genentech. In hiring new employees, we look for people who are inspired by this mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset. The following opportunity exists in our South San Francisco, CA facility: Senior Clinical Trial Manager Job ID: Register to View South San Francisco, CA RESPONSIBILITIES: The Genentech Research and Early Development (gRED) Senior Clinical Trial Manager (Sr. CTM) provides leadership to one or more global Study Teams within an early development program(s). The Sr. CTM is accountable for activities ensuring high quality deliverables are within budget and timelines. Primary Accountabilities and Responsibilities: *Independently lead cross-functional Study Team within Clinical Operations with minimal oversight from the CPL *Accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets *Responsible for vendor selection and management including CRO, IVRS, central lab, imaging vendor *Provide input to the program budget and is accountable for managing overall study budget *Identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate *Partner with CPL to develop and/or present at project teams and management review bodies *Ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines *Conduct protocol and site feasibility assessments *Provide drug supply assumptions to clinical planning team *Delegate and oversee study activities assigned to Clinical Operations as applicable *Provide support, mentoring, and study-specific Training to Clinical Operations staff *Network and share best practices with colleagues to ensure optimal efficiency and consistency in Clinical Operations *Participate in initiatives and/or activities as assigned These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual. Requirements: Minimum: *6+ years study management experience in clinical and drug development *Bachelors degree or equivalent required (scientific or Healthcare discipline preferred). *Working knowledge of international regulatory and ICH GCP guidelines Experience, Skills, Knowledge: *Highly experienced in managing early development phase clinical studies and generally experienced in clinical research/development *Effective leadership of cross-functional teams *Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies *Demonstrated experience in various therapeutic areas *Familiar with global trial requirements *Demonstrated creativity and innovation to Support projects and initiatives *Excellent planning and organizational skills *Flexible and solution focused *High level of initiative and ability to work independently *Strong analytical skills *Strong customer focus *Highly effective verbal and written communication skills in English Other (e.g. Travel): Willingness to travel domestically and internationally, and work across cultures. DIVISION: Exploratory/Early Devt (gRED) REQUISITION NUMBER: 1 Register to View Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. # Register to View . Please use ?Web ? BAJobs? when a source is requested. Genentech is an Equal Opportunity Employer.

Job Title: Clinical Trial Manager Company: Kforce Professional Staffing Location: Cambridge, MA Description: At Kforce Clinical Research, we don't just offer jobs. We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the world's most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies. Using these tools, Kforce is able to better plan and anticipate work loads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home. Currently, one of our top clients is in search of an exceptional Clinical Trial Manager in Cambridge, MA. The Clinical Trial Manager will be responsible for the successful execution of a protocol, including: study start up to archiving of the regulatory documents, interact with the operations team to ensure timelines, deliverables, and data quality are met within budget; handle multiple competing priorities and utilize resources effectively; and provide mentoring guidance, coaching, and feedback to the team. Specific accountabilities: Lead regular monitor meetings Develop, review, and/or provide input into study documents (e.g., monitoring guidelines, CRF instructions, and study budget template) Accountable for facilitating, tracking, and monitoring the progress of study activities Plan, set-up, and manage trial communication plan, including investigator, monitor, and operational team meeting schedules, overall drug supply, and management and provision of other study materials in accordance with project and study level plans Manage/execute operations activities including, but not limited to, investigator meeting planning, study and site start up, site management, database lock activities, site closure and TMF archiving Manage the regulatory document approval process Manage investigator payments and invoices Requirements: Must have Bachelor of Science degree in a biological science or healthcare profession At least four years of clinical research experience including experience in clinical project management Monitoring experience Study start up; Phase II Oncology experience required Hematology experience a plus Understanding of the drug development process Understanding of ICH guidelines and GCP Advanced computer skills Effective oral and written communication skills Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. Kforce Clinical Research has been serving the pharmaceutical industry since 1988. We are truly a career destination and the employer of choice for skilled, dedicated professionals like you. At Kforce, one of our core principles is: Great People = Great Results! This means that we will work to find you the right career match through exceptional customer service, a disciplined process, and personal respect. If you are qualified and interested in the excellent career opportunities we have for you, apply today!

Job Title: Clinical Research Coordinator Company: Reproductive Biology Associates Location: Atlanta, GA Description: Clinical Research Coordinator Clinical Research Coordinator We are looking for an experienced clinical research coordinator to conduct a study comparing two IVF medications. Full time

Job Title: Clinical Project Manager, West Company: Baxter HealthCare Location: Round Lake, IL Description: > > > Job details --> Job details Req ID 41992BR Business Title Clinical Project Manager, West Business Medication Delivery Sub-Business US Region Country United States State/Province Illinois Location of Position Round Lake, IL Shift_ 1st About Baxter Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. Job Description Summary: Responsible for leading Baxter??s Smart Infusion Pump implementation and evaluation projects at customer sites through development of timelines and facilitation / scheduling of internal and external resources. Oversees the development, vetting, and approval of comprehensive, site specific, Master Drug Library (MDL). Manages multiple implementation/evaluation projects through project life cycle, including pre-sale support, coordination of multi-disciplinary team for product implementation, and post-implementation customer satisfaction follow up. Responsible for completion of revenue recognition milestones and adherence to timelines. Serves as customer??s primary point of contact for implementing Baxter Smart Infusion Pumps and supports territory manager as project point of contact in Baxter Smart Infusion Pump evaluations. Essential Duties and Responsibilities: 1. Manage implementations across all functions for the customer: Identify resource requirements and schedules resources as required to ensure safe and efficient implementations and successful evaluations. Coordinate project logistics with multi-disciplinary teams including Pharmacy, Nursing, Biomed, IT, and other key stakeholders Provide ongoing project communications across both Baxter & customer as well as lead customer meetings Coach and lead local sales team and/or customer through the implementation process, where project manager not available to lead process Tailor template project management deliverables (scope documents, milestone status reports, actions/issues lists, etc.) and implementation approaches to specific customer implementations Create and deliver implementation meeting presentations Manage and resolve issues and risks which arise during implementations Manage customer expectations for scope, time, cost, quality and customer satisfaction 2. Collaborates with project stakeholders (both internal and external) to make certain goals set during the pre-contract stage are incorporated as part of the overall implementation planning. 3. Works as part of the implementation team with responsibility for clinical implementation activities. Ensure highest quality implementations via adherence to established clinical models, per Best Demonstrated Clinical Practice policy documents. Provide clinical insight and benchmarking where necessary for key clinical or safety issues. Seek out other resources to consult as necessary. 4. Ensure all resource requirements are met, including, but not limited to clinical trainers, pump delivery, accessory delivery, etc to ensure safe and effective evaluation/implementation. 5. Develops, in conjunction with clinical management, comprehensive project management services plans including CQI activities post-implementation. Performs post-implementation clinical assessment to assist customer with benefits realization of product functionality and workflow. Utilize all available resources to improve safety within customer sites via CQI reporting and benchmarking. 6. Responsible for achieving implementation project milestone targets to ensure business that Baxter can recognize revenue as forecasted. Report any changes to milestone targets in timely manner to key internal stakeholders. 7. Ensures customer satisfaction through measurement tools as established. 8. Assists marketing product managers with market surveillance, customer needs, and future product ideas. Job Requirements Education and/or Experience: 1.Licensed RN or RPh required. 2. Bachelor's Degree preferred. 3. Minimum 7-10 years clinical experience with 5 years clinical project management experience. Three to five years experience installing smart infusion pumps preferred. 4. Advanced degree (MBA, MSN, PharmD) preferred. 5. PMP certification a bonus. Proven experience operating in clinical environments, on patient care units with all levels of clinical managers (RN??s, RPH??s, Anesthesiologists). Must understand and identify clinical issues and be able to predict needs and trends. Project management experience in clinical setting preferred. Strong project leadership skills with ability to manage multiple projects, establish processes and handle competing interests. Process improvement methodology knowledge preferred (SixSigma, Lean Thinking, CQI). Must have strong communication and interpersonal skills. Able to thrive in a matrix environment. Able to interface at all levels of customer and Baxter organization. Extensive Travel is required Demonstrated analytical, problem solving and leadership skills required. Must have excellent oral and written communication skills as well as excellent presentation skills with ability to conduct presentations comfortably to large groups at clinical and executive level Travel Required Yes Doing Work that Matters Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at EOE M/F/D/V.

Job Title: Clinical Trial Manager Company: NetSource, Inc. Location: Titusville, NJ Description: Please note that this is a 15 month contract position. Responsible for global execution of a trial, supervising the delegated activities necessary for the planning, start-up, execution and closure of a clinical trial. 5 Years of experience needed. Global Trial Management is part of Global Clinical Operations and is responsible for performing high quality efficient high output ethical clinical research and development world wide. We develop and rely on well trained motivated people in order to meet the needs of international J and J Pharmacuetical Divisions in adding value to our drug development programmes working in multiple interdependent partnerships. You will manage * from feasibility through to database lock and site closure - phase II-IIIb clinical conducted by academic and healthcare institutions worldwide within quality guidelines, timelines and budget. Preferably you have a university degree or equivalent (biological, science, nursing experience etc). You have at least 5 years experience in the Pharmaceutical Industry in clinical research, minimum 2 years monitoring, or managing clinical trials. For consideration please include Dice # 6802

Job Title: Clinical Project Manager Company: Document Solutions Group, Inc. Location: Malvern, PA Description: As a Clinical Project Manager for DSG, a Clinical Software and Services provider of Technologies for the Pharmaceutical industry, you will act as a liaison with Project Managers and Data Managers at top pharmaceutical companies, taking projects for clinical drug trials from start to completion. The core responsibility is the project management of the capture and maintenance of clinical data from setup to completion of a clinical trial. Project managers with less than 1-2 years experience will be considered Associate/Junior eCaselink Project Managers. Other job duties include:** Act as a liaison with the sponsor organization and it**s site personnel to ensure that DSG meets the client**s requirements** Organize and run project setup meetings** Gather data requirements for the clinical project, based on the drug protocol and client requirements.** Attend meetings with the client at the client site** Create the EDC screens and system edits specification that outlines data field requirements and appropriate edits** Verify functionality to be included in eCaseLink application (DSG**s EDC application)** Obtaining and verifying job specifications** Using DSG**s proprietary software (eCaseLink and CaseLink)** Coordinating and implementing project schedules** Oversee edit specification testing** Provide training and support to end users** Other duties as necessaryRequirements** Bachelors degree or equivalent experience** Minimum 2 years project management experience in the software/pharmaceutical industries** Superior communications and organizational skills** Ability to handle multiple projects concurrently** Customer service orientation and ability to work independently** Strong PC aptitude** Strong management references REQUIRED** Tenacity, assertiveness and desire to succeedCompany HistorySince 1992, we have been providing comprehensive software and services to the Global Pharmaceutical and life sciences industry - the 5th largest industry in the United States with over $700 billion in revenue. DSG has successfully supported over 400 clinical trials with innovative, award-winning technology solutions including our flagship software product eCaseLink EDC (Electronic Data Capture), electronic patient diaries, data management, robust reporting and data analysis tools, and digital on-demand CRF publishing software. DSG delivers clinical trials more efficiently and cost effectively ** without delays. Clients include Top 5 Pharmaceutical, Biotechnology, and Medical Device Companies.DSG offers competitive pay, performance incentives, medical, dental and vision coverage, 401(k), paid vacation, and a casual work environment. DSG has experienced high growth over a span of 15 years and provides dynamic opportunities for the ambitious to achieve even greater success.DSG provides sponsorship for new H1b positions and transfers. If you are interested in the job position, and you don**t yet have an H1b work authorization status, please contact us.

Job Title: CLINICAL TRIAL MANAGER Company: MedFocus Location: Bridgewater, NJ Description: CLINICAL TRIAL MANAGER COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Clinical Trial Manager to work in Bridgewater, New Jersey. Our client is developing leading positions in seven major therapeutic areas. RESPONSIBILITIES: Conduct and completion of clinical trials to include review and management of the CSR process and budget management. Lead the multi-disciplinary team responsible for study completion. Participate in data extraction and tracking for NDA regulatory submissions. Proficient in the use of Clinical Trial Management Systems (Experience with IMPACT is a plus) Regulatory submissions Experience in clinical trial budget management and the CSR process and requirements Experience in Project Management, and clinical applications are a plus Experience in multiple therapeutic areas is a plus Bachelors level degree/RN (or equivalent). No travel or heavy lifting required. At least 3-4 yrs of Experience required. KEYWORDS: Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH & GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable. PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!

Job Title: Sr. Clinical Project Manager, CNS:Exciting & Growing Small/Mid-Size Pharma Co, Chatham NJ Area Company: Cornerstone Search Group, LLC Location: Chatham, NJ Description: Sr. Clinical Project Manager, CNS: Exciting & Growing Small/Mid-Size Pharma Co, Chatham NJ Area Summary: Our client is a successful mid-size pharmaceutical company undergoing tremendous growth. Due to rapid expansion and recent additions to their drug therapies portfolio (CNS), this company has recently opened a new office in the Chatham, NJ area. They are continuing to build their clinical team, and looking to hire an industry-experienced professional to serve as the lead person in clinical project management (CNS). This is an excellent ground-floor opportunity with significant visibility and growth potential. If you are someone with a self-motivated, entrepreneurial spirit and 6-8 years of clinical project management/clinical development experience in the pharmaceutical industry, please read on for further details Location: Chatham, New Jersey area Compensation: Total compensation (base+bonus) will be competitive and could range into the $140k's. In addition, you will receive a strong benefits package, including 401(k) match, medical/dental, tuition assistance, pet insurance, flex-time, etc. Attractive features about this position and company: Attractive New "Ground-Floor" Opportunity: Serve as the clinical project management leader and create your own footprints in a newly-created/growing group. Growing Mid-Size Pharma Company: Work for an exciting, financially stable mid-size pharmaceutical company Exciting Pipeline/Company Vision: You will be an integral part to the success of a company which is looking to supplant themselves as a leader in the CNS area. Growth Potential: As one of the first people in this new office, there will be significant opportunities for growth/visibility/valuable hands-on experience Great Location: Located in the Chatham, NJ area, which is consistently ranked as one of the nicest places in NJ to live and work. Responsibilities: In this role, you will be leading the clinical project management function manage all aspects of new/ongoing clinical trials in the CNS area. Responsibilities will include managing vendors (i.e. CROs, specialty labs, etc), cross-functional operational leadership, clinical protocol development, preparing/implementing clinical development plans, developing/managing study budgets and timelines, resource planning, serving as lead sponsor contact with outside organizations, etc. Requirements: BS/BA (in life science) is required. Advanced degree (MS, MBA) is a plus. At least 6 years of clinical project management/clinical drug development experience working at a pharmaceutical or biotech company Cornerstone's Privacy Policy Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information. Any information provided/shared with us will not to be shared with any parties outside of Cornerstone Search Group without your prior permission. Contact Brian C. Skurka Senior Recruiting Consultant Cornerstone Search Group, LLC 6 Campus Dive Parsippany, NJ 07054 P Register to View Register to View Web/URL: www.cornerstonesg.com About CORNERSTONE SEARCH GROUP Cornerstone is a Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in the heart of New Jersey's Pharmaceutical Corridor. Cornerstonepartners with Pharmaceutical, Biotechnology, and Consumer Healthcare companies to identify, attract and hire accomplished professionals from the Senior Staff through Executive levels that areinvolved in thediscovery, development, and commercialization of drugs and therapeutic treatments for the US and international markets. Cornerstoneoffers a comprehensive range of talent acquisition services including:Retained Search, Performance-Based Retained Search, Contingent Search (for full-time and consulting positions), and Strategic Advisory Services (e.g. organizational structure development, recruitment strategies, and compensation/benefit guidance). Cornerstone has a deep reservoir of industry knowledge andcontactsdue to our single industry focus, ahighly experienced management team committed toprofessional client service, andwe continuously invest in our people, processes, and technology. Cornerstonestrives every dayto meet and exceed our mission statement: Building Better Companies, Building Better Careers Other Opportunities Cornerstone Search Group is currently working on Executive Search & Recruitment assignments in several of the following business areas: Discovery, Clinical Research & Development, Medical Affairs and Commercial/Marketing, and in several of the following functional areas: Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Data Management, Health Economics & Outcomes Research, Market Research, Medical Affairs, Medical Directors, Clinical Scientists, Medical/Drug Information, Medical/Scientific Communications, Medical Writing, Pricing & Reimbursement, Product/Brand Management, QA/QC, Pharmacovigilance & Drug Safety, Regulatory Affairs, Scientists, Sourcing and Pathologist. Please visit our company's web site for a comprehensive listing of available positions/opportunities at www.cornerstonesg.com.

Job Title: Sr Clinical Trial Manager (Hemophilia) Company: Biogen Idec Inc Location: Waltham, MA Description: As a key member of the clinical operations team at Biogen Idec's Syntonix subsidiary, this individual will play a critical role in advancing our hemophilia programs on a global basis with the overall goal of significantly improving treatment options for patients and their families. Relying on a strong understanding of effective clinical trial management, this individual will translate program strategy into actionable clinical operations plans and then ensure cross-functional execution.Key responsibilities include: Plans program feasibility, developing strategies for country selections, CRO/vendors use and evaluations and planning for contingencies for a global Hemophilia program. Establishes effective working relationships with study investigators and coordinators to ensure that timelines and accrual targets are met and site processes comply with SOPs, Regulatory regulations and ICH/GCP guidelines. Coordinates all relevant Clinical Development activities/documents related to Regulatory Submissions (e.g., IB, IND, Annual Reports, BLA, NDA or other regulatory filings). Builds strong relationships with individuals and groups across Biogen Idec to identify opportunities for sharing of best practices and to align activities and process where appropriate. Provides input into creation of program budget and manages Clinical Development elements with an emphasis on identification, resolution and/or escalation of discrepancies. Interacts frequently with external partners, including expert panels, physicians and investigators, CROs, contract laboratories, advisory committees, clinical trial consultants, and cross-functional counterparts from development partner.QualificationsTypically requires at least 5+ years of global drug development with experience managing clinical projects within time, budget, and quality expectations.Experience in Hemophilia and clotting disorders. hematology/oncology clinical research and development very desirable. Prior experience with complex, Phase3 global clinical trials is required.Candidate must have very strong project management experience leading global clinical project effortsNDA/BLA or MAA experience desirable, particularly within an orphan/rare disease therapeutic area.Thorough knowledge of GCP, ICH guidelines and awareness of global regulatory requirements/differences for clinical development.Detail and process oriented, with excellent project management skills, including risk assessment and contingency planning. Demonstrated leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills. Proven excellence in cross-functional matrix and/or cross-cultural partnership setting preferred.EducationBachelor's degree or equivalent experience required, preference for Life Sciences degree or minor ; Advanced degree preferred