Manager, Monitoring Services

CareAbout

About The Position

The Manager, Clinical Monitoring, is responsible for the day-to-day management of Clinical Monitoring department team members (permanent and/or contract), overseeing their performance and training, ensuring adequate monitoring resources, allocating resources to projects, identifying quality issues related to clinical monitoring activities and establishing action plans to address them. The Manager, Clinical Monitoring, contributes to the oversight of clinical monitoring activities for assigned trials.

Requirements

Bachelor's (e.g., Medical, Scientific, Nursing or equivalent health related) degree or related experience will be considered.
Minimum of 6 years of relevant industry experience, of which a period of 3 years is preferable in clinical research monitoring or equivalent experience.
Minimum of 2 years of direct supervision of personnel.
Thorough knowledge of clinical research industry, terminology, and practices.
Thorough knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
Excellent verbal and written communication skills.
Experience with EDC systems; ability to learn required systems quickly and to train others.
Demonstrated ability to meet deadlines, multitask, and prioritize tasks as required.
Ability to make sound decisions based on available information.
Ability to establish and maintain strong working relationships with internal and external customers.
Ability to work both in a team and independently.
Ability to facilitate team meetings and teleconferences.
Ability to present at internal study team meetings.
Proficient with Microsoft Office Word, Excel and PowerPoint.
Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Ability to travel.
Fluency in English is an essential requirement

Nice To Haves

Experience in Phase 1 and Phase 2 clinical trials is preferred.
Previous CRO experience is preferred.

Responsibilities

Provide expertise, strong leadership, and management.
Ensure that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable Standard Operating Procedures (SOPs), regulations, Good Clinical Practice, and study-specific requirements.
Review visit reports and manage any issues brought to their attention by CRA staff and/or the study team and/or Sponsor.
Oversee Corrective Actions/ Preventive Actions (CAPAs) of assigned staff to ensure timely and sufficient resolution.
Track clinical monitoring metrics such as number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings.
May conduct monitoring visits to offer support to project teams.
Participate in the preparation, conduct and resolution of audits and inspections.
Contribute to the development, revision, and implementation of Clinical Monitoring SOPs, processes, and study tools.
Serve as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.
Identify and implement professional development and performance evaluations.
Act as a mentor to team members to ensure growth and career development.
Serve as a point of contact for CRAs and other team members for assigned projects, processes, and/or initiatives.
Ensure projects/studies are resourced appropriately by allocating and/or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned staff.
Conduct Monitoring Oversight Visits to ensure compliance of clinical monitoring team members with regulations, SOP’s, and study requirements.
Prepare and review budgets for RFPs, as assigned.
Participate in Bid Defense Meetings, as assigned.
Perform ongoing reconciliation of clinical monitoring activities against budget.
Perform additional duties assigned by Clinical Monitoring leadership.