Director of Clinical Operations Jobs in Cambridge, 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.
Experienced in late-stage drug development and study start-ups. Background in hepatology Understands GCP, ICH, and relevant CFRs well....
Associate Director, Medical Operations Excellence for US Immunology
- Boston, MA (3 miles from Cambridge, MA)
- 7 hours ago
- Boston, MA (3 miles from Cambridge, MA)
- 7 hours ago
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services...
Associate Director for Research, RPCA
- Newton, MA (3 miles from Cambridge, MA)
- 3 days ago
- Newton, MA (3 miles from Cambridge, MA)
- 3 days ago
Coordinate with Boston College internal departments, such as but not limited to the Institutional Review Board, Office of Sponsored Programs, Transferring and Licensing, and School of Social Work to...
trial management, including supervising staff and CROs.Required experience managing Ex-US trials.Experienced in late-stage drug development and study start-ups.Background in hepatologyUnderstands GCP...
Associate Director for Research, RPCA Boston College
- Chestnut Hill, MA (4 miles from Cambridge, MA)
- 4 days ago
- Chestnut Hill, MA (4 miles from Cambridge, MA)
- 4 days ago
Coordinate with Boston College internal departments, such as but not limited to the Institutional Review Board, Office of Sponsored Programs, Transferring and Licensing, and School of Social Work to...
Extensive knowledge and/or awareness of FDA GCP and Part 11 regulations, EMA and MHRA regulations, ICH Guidelines and European Clinical Trials Directive, 21 CFR part 58, EU PV Modules and an understanding...
Managing Director, Research and Insights
- Boston, MA (3 miles from Cambridge, MA)
- 10 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 10 days ago
Working at Real Chemistry and in the healthcare industry isn't just a job for us. We got into this field for different reasons, but we all stay for the same reason - to uncover insights, make...
\n \n Preferred Qualifications \n \n Experience in pharmaceutical drug development.\n Completion of a medical residency program.\n Completion of a sub-specialty fellowship....
Senior Director, Clinical Research, Atherosclerosis
- Boston, MA (3 miles from Cambridge, MA)
- 11 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 11 days ago
trials (design, operational plans, settings) based on these clinical development strategies Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Atherosclerosis...
Director, Clinical Research, Atherosclerosis
- Boston, MA (3 miles from Cambridge, MA)
- 11 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 11 days ago
Required: Must have experience in industry or senior faculty in academia Minimum of 3 years of clinical medicine experience Minimum of 1 year of industry experience in drug development or biomedical...
- Boston, MA (3 miles from Cambridge, MA)
- 11 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 11 days ago
A comprehensive understanding of drug development (clinical trials, biomarker testing), assay development, and co-development for CDx programs....
Remote WorkAssociate Director Clinical Operations
- Boston, MA (3 miles from Cambridge, MA)
- 11 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 11 days ago
Collaborate with internal teams, including Senior Clinical Operations, Senior Director of Clinical Operations, and Clinical Trial Associates....
Senior Manager/Associate Director, Clinical Operations (Waltham, MA)
- Waltham, MA (6 miles from Cambridge, MA)
- 13 days ago
- Waltham, MA (6 miles from Cambridge, MA)
- 13 days ago
Ensure studies are executed in compliance with internal SOPs and following ICH, EMA, ICH-GCP and other relevant guidances....
Senior Clinical Research Director - Bone Marrow Transplantation
- Cambridge, MA
- 16 days ago
- Cambridge, MA
- 16 days ago
Main Responsibilities: Supervises study Clinical Research Directors / Clinical Scientist of assigned ongoing clinical trials Collaborates with cross functional teams from Clinical Operations, Medical...
- Boston, MA (3 miles from Cambridge, MA)
- 30+ days ago
- Boston, MA (3 miles from Cambridge, MA)
- 30+ days ago
Operations....
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Salary for Director of Clinical Operations Jobs in Cambridge, MA
Required or preferred licenses and certifications for Director of Clinical Operations positions.
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Director of Clinical Operationss in Cambridge, 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
- Implementation
- Budgets
- Institutional Review Board
- ICH GCP
- Clinical Trial Management System
- Study Management
- Biomarkers
- Good Clinical Practice
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Drug Discovery
- Biostatistics
- Computational Biology
- Field Sampling
- Mass Spectrometry
- Medical Affairs
- Method Development
- Drug Development
- Biology
- Scientific Research
- Biochemistry
- Pharmacovigilance
- Stem Cells
- Nuclear Magnetic Resonance
- Immunology
- Gel Electrophoresis
- Biotechnology
- Clinical Trials
- Neuroscience
- Infectious Disease
- Clinical Research
- Clinical Operations
- Oncology
- FDA Regulations
- Research and Development
- Data Collection
- Standard Operating Procedures
- Data Management
- Health Care
- Affirmative Action
- Strategy Development
- Collections
- Military Background
- Investigation
- Written Communication
- Auditing
- Presentation
- Documentation
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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