Senior Director, Clinical Operations, will manage the successful completion of all IND to Post Approval clinical studies within appointed programs, as well as be responsible for assisting with the development of the program budgets and meeting both enrollment and spending targets. Manage and ensure competency of Clinical Operations staff including their knowledge and compliance with SOPs. The Director, Clinical Operations will build and maintain relationships with clinical trial sites and principal investigators plus develop and maintain tools for tracking progress against department goals and objectives. The Director, Clinical Operations will participate in the strategy and development of new trials and participate in the selection of trial sites, vendor selection
Reporting Relationship: Vice President, Research and Development Operations
Leads,directs, and mentors the clinical operations team responsible for management and execution of all clinical trials;
- Manage and oversee the successful and timely execution of all Boston Biomedical clinical trials.
- Select, train and manage Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs) and Clinical Project Managers (CPMs) including their training and compliance with all SOPs and associated regulations.
- Establish and manage trial budgets including enrollment targets. Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending.
- Participate in the
strategyplans of new clinical trials.
- Oversees the development of the clinical component of regulatory submissions (ie. ICF, protocols, CRFs)
- Manages all study-related activities to meet GCP/ICH guidelines;
- Oversees investigator recruitment/selection and the conduct of trials at investigative sites;
- Collaborates with Head, Vendor Management to establish plans and assist with management of CROs and study-related vendors accordingly (inclusive of
- Oversees the clinical operations project leads for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans;
- Tracks study progress ensuring timely data collection, monitoring
anddata cleaning activities;
- Acts as a liaison between
cross functionaldepartments within Boston Biomedical for project-related matters;
- Provides Senior Management with regular study updates/status reports on study execution; and
- Reports directly to the VP, R&D Operations
- MS in life sciences or nursing
- 10 years’ experience in clinical research management, oncology experience required (previous CRA and Project Management experience)
- Experience in all phases of drug development (I-IV)
- Strong leadership skills; Minimum 5 years of direct supervisory experience
- Demonstrated knowledge of and experience with ICH/GCP for global clinical trials
- Hands on experience in the preparation of INDs/NDAs regulatory submissions
- Participated and led Inspection readiness activities
- Strong Written and Verbal Presentation Skills
- Willing to travel up to 10%
- Excellent communication, problem-solving and organizational skills
- Computer proficiency including Microsoft Office applications
Job Location: Cambridge, MA
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