Manager / Senior Manager, Clinical Science
The Manager/Senior Manager, Clinical Science will be responsible for leading or supporting the execution, and reporting of clinical trial activities for Phase 1 to 3 clinical trials, ensuring adherence to study timelines, budgets, Quality Plans and applicable FDA/ICH/NIH guidelines. This role liaises with vendors and partners as needed, directing CRO management and oversight of outsourced clinical activities.
- Contributes to the writing and/or reviews protocols, protocol amendments, informed consent forms, annual reports, investigator’s brochure, and regulatory submission documents.
- Participates in interim reporting requirements to DSMBs and NIH.
- Participates in the development of outsourcing strategies, including the selection of CRO’s and other external vendors, the development of clinical trial budgets, and issue escalation.
- Manages/monitors clinical study activities and execution by the CRO’s.
- Participates in the development of EDC and IWRS specifications for the clinical studies
- Responsible for leading an internal trial management team, to ensure that all studies are carried out according to the study protocol, SOPs, applicable GCP/ICH guidelines.
- Contributes to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team.
- Participates in clinical operations process improvement initiatives to address clinical needs (e.g., development of investigator database, standardized CRF modules, etc).
- Presents trial operations topics at investigator meetings and study team training meetings.
- Ensure inspection readiness at all times for assigned trials
- B.S/B.A. degree in a science-related field
- 5-7 years of clinical research experience, including clinical trial execution and reporting with progressively increasing clinical research experience and direct experience with pharmaceutical, biotech, and CROs
- Must have experience with study management of international trials
- Experience with anti-infective trials preferred
- Familiarity with data management, as well as electronic data capture tools and 21CFR11 requirements
- Excellent knowledge of ICH/GCP guidelines
- Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, electronic data capture (EDC) systems, clinical trial management systems (CTMS) and electronic trial master file (eTMF)
- Strong medical/scientific writing skills
- Experience participating in authoring of and/or review of protocols and clinical sections of clinical documents
- Demonstrated organizational and time management skills
- Excellent interpersonal communication skills, and demonstrated ability to prepare and deliver verbal presentations which are clear, focused and concise
- Demonstrated teamwork skills, including cooperation, willingness to learn from others, and the ability to share relevant information
- Experience anticipating and addressing key technical and operational problems in clinical research that could impact the broader process or team
- Up to 20% travel may be required
Equal Employment Opportunity/M/F/disability/protected veteran status