Global Biotech company with US Headquarters outside Boston, MA is expanding.
The role of Senior Manager, Clinical Science is to guide and participate in all aspects of clinical development and study management under the direction of the head of clinical development. Responsibilities include scientific support to planned and ongoing clinical trials. May support more than one clinical protocol. Works cross-functionally to ensure alignment across studies and to achieve the corporate objectives for programs.
Main Areas of Responsibilities
- Authors, individually or in collaboration with internal and external partners, clinical materials, included but not limited to:
- Clinical Investigation Plans and Synopses based on completed Study Designs
- Investigators’ Brochures
- Patient Informed Consents
- Clinical Study Reports
- Clinical Evaluation Plans and Reports
- Clinical Literature Review Reports
o Author additional clinical materials as needed
o Annual Reports and when needed, ISE/ISS
- Assist with reviewing topline results and preparing presentations for senior management as needed.
- Contributes to, and reviews relevant documents and plans, including but not limited to:
- Monitoring plan
- Data management plan
- Statistical analysis plan.
- Reviews, tests, and approves specifications and edit checks for internal and external systems such as EDC and IVRS. As needed, reviews and trends clinical queries.
- Monitors and reviews aggregate clinical data for trends/errors during the course of assigned studies. Identifies potential clinical data issues and recommends to management means of risk mitigation. Collaborates with Medical Affairs and Clinical Affairs in the review and management of safety related observations and issues.
- Interacts with R&D and Clinical Operations to ensure adequate clinical supplies for the clinical trial. Oversees the shipment of Investigational Product supply, packaging, and labeling.
- Supports planning and conduct of investigator meetings, Advisory Boards, Steering Committees, and DMCs
- . Develop and deliver study specific training presentations as needed.
- Provides support of publications
· Works with Project Management to establish, report, and update timelines and budgets.
· Support the development and management of study budgets for clinical programs. Track and manage site budgets efficiently and provide timely resolution to financial inquires.
· Evaluates potential vendors. Work with Contracts Management/Procurement to receive/review bid proposals, meet vendors, and contribute to vendor specifications development. Address any escalated issues related to contract negotiations as needed.
· Contributes to the development and review of SOPs, training guidances, and templates as needed.
- May manage direct reports or supervise clinical study team member(s) as assigned. Recruits, develops, and supervises direct report(s). Conducts employee performance evaluations and provides direct report(s) with guidance on technical/project related issues and employee relations. Mentors and guides junior staff members to maintain team morale and high quality of deliverables..
- May develop and deliver training related to study execution and COMPANY policy and procedures within department and cross-functionally.
- Contributes to process improvement.
- May perform additional research and contribute to submissions activities and/or responses to FDA inquiries as needed.
Education and Background Requirements
- 10 years of experience in Medical Technology Industry or Biotechnology Industry
- PharmD, PhD, or MPH Preferred
- Must have managed team in past and have strategy experience
- Demonstrated experience supporting and managing the development, implementation, and completion of clinical trials and/or programs
- Experience with all stages of clinical development
- Some document authorship experience (e.g., protocols, study reports, manuscripts)
- Site/vendor management and data review experience
- Knowledge of medical device development and relevant regulations, including but not limited to, FDA GCP/ICH regulatory guidelines
- Strong understanding of clinical trial design and basic knowledge of statistics
- Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
- Must possess excellent skill/ability in the following:
- Oral and Written Communication
- Planning and Organizing
- Decision Making, Judgment, and Problem Solving
- People Relationships, Team Building, Motivating Employees, and Influencing Others
- Mentoring and Developing People
