Director of Clinical Operations Jobs in Needham, MA
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.
RESEARCH PROJECT COORDINATOR, Center for
- Boston University
- Boston, MA (10 miles from Needham, MA)
- 4 days ago
- Boston, MA (10 miles from Needham, MA)
- 4 days ago
Key Responsibilities Coordinate and support clinical research studies and trials Work with the Institutional Review Board (IRB) to develop and update study protocols Ensure compliance with ethical and...
In PersonExecutive Director, Research & Developme
- Moderna Services, Inc.
- Cambridge, MA (9 miles from Needham, MA)
- 4 days ago
- Cambridge, MA (9 miles from Needham, MA)
- 4 days ago
. * Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas. * Embed risk-based quality management principles into...
In PersonAssociate Director, Clinical Operations Study Lead (COSL)
- BlueRock Therapeutics
- Cambridge, MA (9 miles from Needham, MA)
- 6 days ago
- Cambridge, MA (9 miles from Needham, MA)
- 6 days ago
Excellent knowledge of clinical trial design, operational systems (CTMS, eTMF, EDC), and regulatory requirements (ICH-GCP, FDA, EMA)....
In PersonMedical Director, Clinical Research- CVM
- Alnylam Pharmaceuticals
- Cambridge, MA (9 miles from Needham, MA)
- 6 days ago
- Cambridge, MA (9 miles from Needham, MA)
- 6 days ago
for the associated clinical trials....
HybridResearch Project Coordinator, Center for Regenerative Medicine
- Boston University
- Boston, MA (10 miles from Needham, MA)
- 7 days ago
- Boston, MA (10 miles from Needham, MA)
- 7 days ago
Specific duties will involve: Interacting with the Institutional Review Board (IRB) to generate and update study protocols and ensure compliance with ethical and regulatory guidelines....
In PersonSenior Clinical Research Director - Oncology
- Sanofi
- Cambridge, MA (9 miles from Needham, MA)
- 8 days ago
- Cambridge, MA (9 miles from Needham, MA)
- 8 days ago
As a Senior Clinical Research Director (Senior CRD) within the Oncology Therapeutic Area, you will lead the clinical trial strategy for one or more multiple myeloma assets, creating synergies across...
In PersonClinical Research Director - Immunology and Inflammation
- Sanofi
- Cambridge, MA (9 miles from Needham, MA)
- 8 days ago
- Cambridge, MA (9 miles from Needham, MA)
- 8 days ago
The Clinical Research Director (CRD), Immunology and Inflammation Therapeutic Area, Solid Organ Transplant focus, is responsible for the development, execution and reporting of clinical trials in support...
In PersonAssociate Director of Research Admin.
- Harvard University
- Boston, MA (10 miles from Needham, MA)
- 12 days ago
- Boston, MA (10 miles from Needham, MA)
- 12 days ago
Job-Specific Responsibilities: The Associate Director of Research Administration is a School and University signatory with primary responsibilities throughout the lifecycle of a research project....
In PersonDirector Research Governance and Transformation, Research and Sponsored Programs
- Boston Medical Center
- Medford, MA (10 miles from Needham, MA)
- 12 days ago
- Medford, MA (10 miles from Needham, MA)
- 12 days ago
Director Research Governance and Transformation Department: Research and Sponsored Programs Schedule: 40 hours per week, Remote POSITION SUMMARY: The Director, Research Governance & Transformation...
In PersonAssociate Director, Research Portfolio Management & Scientific Operations
- Modex Therapeutics Ltd.
- Weston, MA (6 miles from Needham, MA)
- 12 days ago
- Weston, MA (6 miles from Needham, MA)
- 12 days ago
Qualifications Required Qualifications PhD or equivalent advanced degree in Immunology, Oncology, Cell Biology, Molecular Biology, or a related discipline. 8+ years of relevant biotech or pharmaceutical...
In PersonClinical Research Director, Rare Diseases
- Sanofi
- Cambridge, MA (9 miles from Needham, MA)
- 13 days ago
- Cambridge, MA (9 miles from Needham, MA)
- 13 days ago
Job title: Clinical Research Director - Rare Diseases Location: Cambridge, MA / Morristown, NJ About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research...
In PersonAssociate Director of Research Administration
- Harvard University
- Boston, MA (10 miles from Needham, MA)
- 14 days ago
- Boston, MA (10 miles from Needham, MA)
- 14 days ago
Company Description By working at Harvard University, you join a vibrant community that advances Harvard's world-changing mission in meaningful ways, inspires innovation and collaboration, and...
RemoteDirector, Research Compliance and Human Research Protection
- Broad Institute
- Cambridge, MA (9 miles from Needham, MA)
- 23 days ago
- Cambridge, MA (9 miles from Needham, MA)
- 23 days ago
Health savings account Paid holidays Disability insurance Health insurance Dental insurance 401(k) Paid time off Family leave Parental leave Employee assistance program Vision insurance Qualifications Clinical...
In Person- Penn State Health
- Cambridge, MA (9 miles from Needham, MA)
- 23 days ago
- Cambridge, MA (9 miles from Needham, MA)
- 23 days ago
Sanofi Careers English Sign In Search for Jobs Clinical Research Director - Rare Diseases page is loaded Clinical Research Director - Rare Diseases Apply locations Cambridge, MA Morristown, NJ time...
In PersonSenior Medical Director, Clinical Research - Hepatology
- TalentBurst
- Cambridge, MA (9 miles from Needham, MA)
- 28 days ago
- Cambridge, MA (9 miles from Needham, MA)
- 28 days ago
research and clinical trial design, including biostatistics, regulatory agency organization, guidelines, and practices Ability to effectively present ideas and document complex medical/clinical concepts...
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Director of Clinical Operationss in Needham, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Clinical Operations position
- Budgets
- Cell Biology
- Good Clinical Practice
- ICH Guidelines
- Study Management
- Institutional Review Board
- Biomarkers
- ICH GCP
- Clinical Trial Management System
- Drug Development
- Computational Biology
- Medical Affairs
- Biostatistics
- Genomics
- Scientific Research
- Gene Therapy
- Pharmacovigilance
- Stem Cells
- Cancer Research
- Bioinformatics
- Drug Discovery
- Medical Writing
- Biology
- Immunology
- Epidemiology
- Clinical Trials
- Clinical Operations
- Clinical Research
- Biotechnology
- Hematology
- Neuroscience
- Research and Development
- FDA Regulations
- Oncology
- Standard Operating Procedures
- Public Health
- Data Management
- Masters In Education
- Health Care
- Risk Management
- Strategy Development
- Collections
- Military Background
- Written Communication
- Investigation
- Presentation
- Documentation
- Mentoring
- Interpersonal Skills
- Implementation
- Reporting
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Leadership
- Communication Skills
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