The Clinical Operations Professional will report to VP and Head, Clinical Operations and Project Management.
Job OverviewResponsible for all operational aspects of assigned global clinical research activities and will liaise closely with other departments as well as with CRO/vendors. Responsible for appropriate execution and oversight of clinical operational development for several trials in various indications. Accountable for all activities associated, directly or indirectly with trial execution and clinical development, reporting and submission activities of the compound, as appropriate. Job title/role can be tailored to the right individual based on a combination of strengths and experience
Responsibilities and Duties
- Oversee and manage clinical operations activities to successfully execute the assigned clinical trial globally.
- Ensure that all work is carried out in strict adherence with relevant protocols, SOPs, and in compliance with FDA and global health authority regulations and guidelines, as well as ICH/GCP
- Oversees study operational teams and manages resources to ensure that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.
- Actively contributes to Clinical Operations departmental activities and process improvement
- Ensure timely feedback on study deliverables and reporting to senior leadership.
- Develop, amend, and review clinical documents such as protocols, ICFs, Investigator Brochures, clinical reports, pharmacy manual and any other documents/plans supporting multiple clinical
- Develop standards for internal documents such as: protocols, ICFs, safety management plans,
- Training and oversight of all vendors associated with the assigned clinical trial.
- Coordinate and drive clinical development programs with appropriate U.S. and International focus.
- Provide routine direction, guidance and mentorship to clinical operations
- Prepare or supervise preparation of a clinical monitoring plan for each project with realistic
- Supervise conduct of clinical programs to ensure on time and on budget delivery of clinical
- Manage staff to monitor clinical programs and studies for protocol compliance, user interface with product, and accuracy of
- Prepare and manage the annual clinical operations
- Ensures accurate documentation and control of all essential study documents, with the support of QA/Compliance.
- Oversee the development of program and study timelines and
- Oversee external vendors including research organizations, CROs, and central
- Review and approve all research agreements and confidentiality requirements.
- Any other responsibilities assigned by direct manager
- Bachelor’s degree in Life Sciences, Pharmacy or Medicine required; advanced degree preferred, i.e. PhD, PharmD, MS, MPH.
- At least 7+ years of clinical research experience in a pharmaceutical, biotech, or medical device industry is required; including 4+ years of clinical program management experience.
- Experience managing a CRO partner in the conduct of clinical studies is required.
- Knowledge and understanding of current regulations related to Phase I through IV clinical research.
- Strong working knowledge of IRB regulations, GCP/ICH guidelines.
- Knowledge of project management tools and practices.
- Ability to understand and review detailed clinical reports.
- Deep understanding of therapeutic area.
- Experience managing a team of Clinical Operations staff with a demonstrated track record of effective clinical management.
- Experience managing a budget and other concurrent multiple projects.
- Solid basis in scientific approach and an ability to deal with in-depth technical information.
- Fosters a high degree of scientific credibility with clinical agencies.
- Demonstrated ability to manage conflict situations.
- Ability to comfortably interact and clearly communicate with individuals at all levels of the organization including working closely with senior management.
- Excellent verbal and written communication skills.
- Ability to multi-task and prioritize.
- Experience in Clinical Research Monitoring and Clinical Project Management; Comprehensive knowledge of Microsoft Word, Excel and PowerPoint.