Manager, Clinical Operations Site Management (COM)
Location: United Kingdom
Requisition Number: 1092
Position Title: Manager, Clinical Operations Site Management
Base location: UK
SUMMARY: Responsible for providing management of assigned Clinical Research Associates. This includes, but is not limited to, ensuring CRAs’ work effectiveness, optimal utilization and performance.
Tasks may include but are not limited to:
- Responsible for interviewing and selecting CRA/IHCRA candidates
- Ensure consistent onboarding of permanent and contracts CRAs/IHCRAs
- Ensure CRAs are properly and timely trained to perform all types of visits as well as other billable monitoring activities
- Provide on-site mentoring for CRAs through observation or site assessment visits
- Establish regular communication and1:1 calls with CRAs/IHCRAs to review and discuss quality metrics (SVR compliance, SDV metrics, TMF readiness, Expense reports submissions, project status, etc.)
- Manage the quality of assigned CRAs/IHCRAs
- Act as point of escalation for CRA/IHCRA performance issues on projects
- Review Timecards including review and approval of hours billed by contractors
- Review the accuracy of Sciforma assignments and workload
- Conduct performance appraisals, rewarding and disciplining employees, addressing employee relations issues and resolving problems
- Write and conduct CAPAs when necessary; Support Directors of Clinical Operations
- Approve CRA/IHCRA PTO requests
- Review and approve CRAs/IHCRAs non-billable expenses
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Ability to understand multiple study protocols.
- Superior oral and written communication skills.
- Strong planning and organizational skills.
- Good interpersonal skills.
- Experienced problem solving/decision making skills.
- Good attention to detail.
- Understanding of clinical research principles and process, data collection and editing skills.
- Ability to navigate in EDC software (InForm, Medidata, etc.)
- Strong knowledge of FDA regulations, ICH Guidelines and HIPAA.
- Understanding of standard operating procedures.
- Knowledge of therapeutic areas.
- Knowledge of Word, Excel and Outlook
- Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and six years clinical research experience as a clinical research associate OR
- Two-year college curriculum (unless nursing degree then see requirement above) or equivalent education/training and seven years clinical research experience as a clinical research associate OR
- Eight years of clinical research experience as a clinical research associate or other position directly related to clinical research with a pharmaceutical or biotechnology company
- Two years management experience
- Travel required
- Passport required
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
Employment Type: Regular
Community / Marketing Title: Manager, Clinical Operations Site Management (COM)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.