The Clinical Trial Manager is responsible for the day-to-day leadership and management of monitoring services for clinical projects, including direct communication and interaction with investigative sites, Clinical Research Associates (CRAs), and the project Sponsors. This position ensures the on time and high quality delivery of: project specific on-site and remote monitoring services; accountability for clinical monitoring team training compliance; tracking of critical project tasks; strategic and tactical study enrollment support including, project specific enrollment planning; and project accountability for CRA utilization.
Job Duties and Responsibilities:
- Ensure project consistency within and across assigned projects by following Clinipace and/or sponsor SOPs, guidelines, and plan documents.
- Create and manage the Clinical Monitoring Plan (CMP), including regular review (annual at a minimum) and updates to the plan; in conjunction with the Project Manager (PM).
- Review the Project Management Plan (PMP).
- Timely CRA trip report review, management, resolution and escalation. Includes tracking of trip report packet (confirmation letter, report, follow up letter) submissions.
- Timely review of protocol deviation, site action items, and frequently asked questions. Track and escalate items as appropriate.
- Oversee clinical portion of the Trial Master File (TMF) and conduct periodic review for completeness.
- Responsible for ongoing analysis of enrollment activities/trends and escalation/mitigation to PM/Sponsor as appropriate. Works with PM to develop strategic and tactical plans for ensuring enrollment targets are met.
- Work with PM to develop study newsletters.
- Responsible for project resource projections and ensure appropriate CRA staffing. Remove CRAs through planned attrition according to study timelines and budget projections.
- Responsible for assuring the quality of the clinical monitoring deliverables and for identifying and mitigating risks.
- Manage monitoring team site assignment and visit schedules to ensure CMP metrics are maintained.
- Oversee CRAs completion of remote site management activities.
- Conduct project co-monitoring visits and team training to assure the quality of the clinical monitoring deliverables and for identifying and mitigating risks.
- Provide coaching/mentoring to the monitoring team.
- Develop project-specific training materials for team.
- Provide project specific performance feedback to CRA team, PM and Line Management.
- Conduct internal team calls and Sponsor calls (as needed).
- Serve as site/CRA contact for protocol clarifications and subject enrollment.
- Serve as Sponsor contact for monitoring/site issues.
- Relate project status and issues to CRAs and PM weekly at minimum.
- Responsible for coordination and management of the clinical monitoring budget and scope of work for monitoring activities.
- Assist the PM with coordination and management of grant administration and project invoicing.
- May review and approve weekly project labor and pass through expenses for CRAs.
- Track monitoring services billing units and report to Project Manager monthly.
- Make updates to study specific CTMS and/or project working files as appropriate.
- Participate in monthly project review meeting and provide budget projections for monitoring services units.
- Monitor and plan for resolution of data backlog by working with clinical management.
- Collaborate with Lead Data Manager to develop CRF completion guidelines and edit specifications.
- Deliver Clinical Monitoring portion of a bid defense presentation.
- Support in the development of working relationships with regulatory authority and IRB/IEC personnel within the constraints of any local guidelines and regulations.
- Attend project and department meetings.
- Complete weekly time and expense entries.
- Maintain good standing with internal training requirements.
- May assume CRA duties and responsibilities when needed.
- Conduct other activities as needed for a given project.
- Provides project work direction to regional/office based CRAs, Internal Clinical Research Associates (ICRAs) and CTAs.
- In some regions, may identify and hire CRAs/CTAs and/or provide direct line management.
- College degree desired, preferably with a Healthcare or Life Science degree or equivalent experience
- 4 + years of Clinical Research Associate (CRA) experience or equivalent preferred.
- 0-2 years of Clinical Trial Management (CTM) experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the role.
- Specific therapeutic experience may be required (e.g. infectious disease, oncology, etc.)
- In some regions, specific licensure may be required (e.g. Pharmacist, Registered Nurse, etc.)
- Strong written and verbal communication skills
- Able to analyze information, set strategy and follow plan through completion
- Fosters active exchange of information and ideas
- Strong interpersonal skills; ability to establish and maintain strong and harmonious relationships with both internal and external customers
- Represents the company externally as Clinipace brand ambassador
- Expert monitoring skills to independently conduct all types of site monitoring visits
- Exceptional computer skills and ability to work across multiple technologies
- Strong presentation skills
- Comprehensive knowledge of GCP/ICH guidelines
- Proficiency in medical terminology
- Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
- Exceptional attention to detail
- Superior problem-solving skills
- Works successfully in a matrix environment
- Ability to manage multiple vendors
- Management of global studies preferred
- Exceptional time management and organizational skills
- Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding)
- Ability to work remotely, if required.
- Valid passport required in the case of international business travel.
- Between 10% to 20% travel, as needed.
The company will not accept unsolicited resumes from third party vendors.