Director of Clinical Operations Jobs in Massachusetts
A Director of Clinical Operations in the biotechnology industry oversees the planning, implementation, and management of clinical trials and research. They are involved in the development and execution of clinical strategies, and work collaboratively with professionals in regulatory affairs, drug safety, data management, and project management. Their work is crucial for ensuring adherence to protocols, regulatory requirements, and ethical standards, as well as achieving the company's clinical objectives. They are also responsible for managing teams, allocating resources, and overseeing the budgeting process.
The Director of Clinical Operations should ideally hold a degree in life sciences or a related field, with advanced degrees often preferred. Certifications in clinical research such as Certified Clinical Research Professional (CCRP) can be beneficial. They should have extensive knowledge of clinical trial management and regulatory compliance, coupled with exceptional leadership, strategic planning, and problem-solving skills. Prior to this role, an individual might hold positions such as Clinical Project Manager, Clinical Trials Manager, or Clinical Research Associate.
POSITION OVERVIEW: Reporting to the Senior Director, Research Quality Assurance, the Associate Director/ Director of RQA will be responsible for developing, implementing, and overseeing Good Clinical...
Remote WorkOperations....
Experience with rare disease and/or pediatric trials also preferred Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process...
Reporting to the Senior Director, Clinical Operations Excellence, Associate Director, Clinical Operations is responsible for leading projects to support the execution of clinical studies aligned with...
Remote WorkResearch Director, Wellness and Recovery after Psychosis Program
- Boston, MA
- 13 days ago
- Boston, MA
- 13 days ago
Review Board (IRB) to oversee submissions, correspondence, and regulatory binders, including administrative amendments Leads the development and writing of proposals to obtain funding for ongoing and...
Director/Associate Director Clinical Operations 2053911Location: Watertown, MA (Hybrid)Focus: Immunology/InflammationJob Overview: The Clinical Operations Manager will lead our client's clinical development...
Chief Scientific Officer- Preemptive Health & Medicine
- Cambridge, MA
- 14 days ago
- Cambridge, MA
- 14 days ago
Partner with individuals in the regulatory and government space to ensure pathway for clinical trials, approvals and commercial environment develops for preemptive health....
Site: The General Hospital Corporation At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our missionfrom doctors, nurses, business people and tech...
Familiarity with ICH Good Clinical Practices (GCP) consistent with registration clinical trials (FDA Guidance for Industry for Computerized Systems used in Clinical Trials (Title 21 CFR Part 11) preferred...
RESEARCH STUDY COORDINATOR, School of Medicine, Anatomy & Neurobiology
- Boston, MA
- 19 days ago
- Boston, MA
- 19 days ago
RESEARCH STUDY COORDINATOR, School of Medicine, Anatomy & Neurobiology Job Description RESEARCH STUDY COORDINATOR, School of Medicine, Anatomy & Neurobiology Category Boston University Medical...
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations....
Associate Director Research, In Vitro Antibody Discovery
- Boston, MA
- 25 days ago
- Boston, MA
- 25 days ago
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
Associate Director, Clinical Operations Job Summary As Associate Director, Clinical Operations within the Development Operations organization, you are an integral part of the leadership team....
Job#: 2063990 Job Description: Director, Clinical Operations 2063990 Location: Boston, MA (Onsite) Focus: Oncology Job Overview: In this role, you will spearhead oncology trials, leading from planning...
guidelines in clinical trials Prior regulatory inspection experience preferred Experience developing and implementing program-level plans including reporting tools, timelines, budgets Ability to collaborate...
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Salary for Director of Clinical Operations Jobs in Massachusetts
Required or preferred licenses and certifications for Director of Clinical Operations positions.
Highest Education Level
Director of Clinical Operationss in Massachusetts offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Clinical Operations position
- Mentoring
- Implementation
- Budgets
- ICH GCP
- Institutional Review Board
- Clinical Trial Management System
- Study Management
- Biomarkers
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Cancer Research
- Drug Discovery
- Biostatistics
- Pharmacovigilance
- Computational Biology
- Field Sampling
- Medical Affairs
- Cancer Biology
- Bioinformatics
- Drug Development
- Virology
- Scientific Research
- Biochemistry
- Biology
- Immunology
- Biotechnology
- Neuroscience
- Clinical Trials
- Infectious Disease
- Clinical Operations
- Clinical Research
- Oncology
- FDA Regulations
- Medical Device Sales
- Research and Development
- Public Health
- Data Collection
- Standard Operating Procedures
- Data Management
- Engineering
- Health Care
- Affirmative Action
- Strategy Development
- Collections
- Military Background
- Investigation
- Presentation
- Documentation
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Project Management
- Research Skills
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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