Director of Clinical Operations Jobs in Newton, 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.
- Boston, MA (6 miles from Newton, MA)
- 6 days ago
- Boston, MA (6 miles from Newton, MA)
- 6 days ago
A comprehensive understanding of drug development (clinical trials, biomarker testing), assay development, and co-development for CDx programs....
Remote WorkDirector, Research & Development
- Salem, MA (17 miles from Newton, MA)
- 7 days ago
- Salem, MA (17 miles from Newton, MA)
- 7 days ago
Strong understanding of FDA, EMA, ICH guidelines, and cGMP requirements. Excellent leadership, cross-functional collaboration, and program management skills....
Senior Clinical Research Director, Ophthalmology
- Cambridge, MA (3 miles from Newton, MA)
- 8 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 8 days ago
trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD)....
Director, Clinical Operations Excellence
- Cambridge, MA (3 miles from Newton, MA)
- 11 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 11 days ago
expert and primary point for Development Operations SOPs, process oversight, and good clinical practice (GCP) Drives gap analysis and reconciliation of Dev ops-owned SOPs; and management of SOPs per...
Director, Clinical Operations - Ph III 2070439
- Cambridge, MA (3 miles from Newton, MA)
- 15 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 15 days ago
Primary Job Requirements: BA/BS degree and over 10 years in clinical trial management, including supervising staff and CROs. Required experience managing Ex-US trials....
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...
Director, Clinical Operations - ph III
- Cambridge, MA (3 miles from Newton, MA)
- 18 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 18 days ago
Director, Clinical Operations - Ph III 2070439Location: Cambridge, MA (Hybrid)Science/ Focus: VariousJob Overview: This role will spearhead global Phase 3 study executions, oversee CRO and vendor management...
Associate Director for Research, RPCA Boston College
- Chestnut Hill, MA (2 miles from Newton, MA)
- 19 days ago
- Chestnut Hill, MA (2 miles from Newton, MA)
- 19 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...
Managing Director, Research and Insights
- Boston, MA (6 miles from Newton, MA)
- 25 days ago
- Boston, MA (6 miles from Newton, MA)
- 25 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...
Director, Medical Director, Clinical Research
- Cambridge, MA (3 miles from Newton, MA)
- 25 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 25 days ago
\n Comprehensive knowledge of clinical trial methodology (industry or academic) and relevant regulatory and compliance requirements....
Senior Director, Clinical Research, Atherosclerosis
- Boston, MA (6 miles from Newton, MA)
- 26 days ago
- Boston, MA (6 miles from Newton, MA)
- 26 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 (6 miles from Newton, MA)
- 26 days ago
- Boston, MA (6 miles from Newton, MA)
- 26 days ago
Specifically, The Director May Be Responsible For: Planning clinical trials (design, operational plans, settings) based on these clinical development strategies Monitoring and managing the conduct of...
Administrative Director, Research
- Boston, MA (6 miles from Newton, MA)
- 45+ days ago
- Boston, MA (6 miles from Newton, MA)
- 45+ days ago
Site: The General Hospital Corporation At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech...
Research Study Coordinator, Infectious Diseases
- Boston, MA (6 miles from Newton, MA)
- 45+ days ago
- Boston, MA (6 miles from Newton, MA)
- 45+ days ago
review board (IRB) submissions, amendments, and reportable events Oversees the launch and provides ongoing support for the study, including logistical support for workshop sites....
Executive Director, Clinical Operations
- Boston, MA (6 miles from Newton, MA)
- 30+ days ago
- Boston, MA (6 miles from Newton, MA)
- 30+ days ago
Join us as the Executive Director of Clinical Operations reporting to the Head of Global Clinical Development Operations....
Demographic Data for Newton, MA
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Salary for Director of Clinical Operations Jobs in Newton, MA
Required or preferred licenses and certifications for Director of Clinical Operations positions.
Highest Education Level
Director of Clinical Operationss in Newton, 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
- Affirmative Action
- Budgets
- Institutional Review Board
- ICH GCP
- Clinical Trial Management System
- Study Management
- Biomarkers
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Drug Discovery
- Biostatistics
- Method Development
- Drug Development
- Computational Biology
- Scientific Research
- Biology
- Pharmacovigilance
- Immunology
- Gel Electrophoresis
- Biotechnology
- Clinical Trials
- Clinical Research
- Clinical Operations
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Process Development
- Standard Operating Procedures
- Product Development
- Program Management
- Health Care
- Engineering
- Strategy Development
- Risk Management
- Collections
- Process Improvement
- Investigation
- Team Management
- Auditing
- Presentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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