Job Description
POSITION TITLE: Clinical Manager DEPARTMENT: Clinical Operations REPORTS TO: a) Functional: Manager/ Director level in the Clinical Operations Department b) Project: Project Manager POSITION SUMMARY: The Clinical Manager (CM) is responsible for all clinical activities at the project level. The CM directs, supervises and supports all clinical staff on the project team; liaises with the customer's clinical team and collaborates with project team members in other functional areas to ensure delivery within contractual obligations. The Clinical Manager (CM) is accountable for delivery of clinical activities at the project level. The CM will successfully meet contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The CM maintains a proactive, positive, results oriented work environment. The current document describes all the activities and responsibilities for the CM position. However, because Clinical Management is also a functional role within the project, this specific function may be delivered by employees with a different job title (e.g. Senior CRA for less complex studies). ACCOUNTABILITY The Clinical Manager: • Ensures the effective selection, initiation and motivation of clinical study sites • Plans and drives patient recruitment and retention • Is responsible for ensuring that the clinical team adhere to the appropriate training needs and performance indicators to ensure the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP, protocol and client requirements • Takes the initiative to move the project/program forward and leads in country and global projects where applicable • Is customer focused on both internal and external customers RESPONSIBILITIES 1. For clinical success: • Leads and manages the clinical start-up and monitoring teams with focus on deliverables • Supports Project Management in the development and review of the protocol/study design, case report forms, informed consent forms and other documents • Plans and conducts initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance where applicable • Assists the project team in the creation and maintenance of the Trial Master File according to the CRO or client SOPs • Develops a clinical monitoring plan as well as clinical monitoring tools • Prepares a risk management plan to mitigate unexpected events in the conduct of the trial • Prepares and executes a site and patient recruitment and retention plan • Drives the successful activation of trial sites according to time, quality/scope and budget parameters • Serves as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required • Ensures effective communication plans are in place for the clinical team • Monitors the preparation and timely completion of all monitoring visit reports, reviews them for appropriate content, and ensures effective follow up and resolution of site issues • Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member • Works with the Data Management team to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk • Works with the Project Manager (PM) to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues • Escalates issues and provides escalation path for the team • Attends project reviews and customer meetings as required • Supports study audits and responds to audit reports • Performs any other duties required to ensure the success of the trial and the CRO 2. For commercial success: • Prepares forecasts for staff utilization over the life of the study • Works with the PM and appropriate line managers to ensure team members are adequately assigned to the project and the project is appropriately resourced over project duration • Assists the PM to ensure appropriate transition planning and stakeholder communication for any change in staff • Provides Time Entry Guidelines to the clinical staff, and applicable training • Identifies out-of-scope tasks from the clinical team and ensures pre-approval of these tasks • Identifies, recruits and manages central vendors as required per project scope 3. Other: • Provides performance feedback on project team members for annual appraisals • Mentors and trains junior level staff • Acts as a resource for other CMs and seeks opportunities to share knowledge-base • Participates in corporate initiatives and actions that ensure the continued success of the company • Serves in dual CM/PM role on smaller, clinical-only studies as required • Other activities as designated EDUCATION, SKILLS & COMPETENCIES: 1. Educational background • Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (i.e. registered nurse); or equivalent work experience required. • Read, write and speak fluent English; and fluent in host country language 2. Experience Level 1 • Minimum 3+ years of clinical research required • 2+ years monitoring experience preferred • Working knowledge of FDA, European Regulatory and EC procedures as applicable Level 2 • Same accountability as Level 1 • Participate in accompanied/quality monitoring assessment visits • Provide performance feedback on CRAs for annual appraisals • At least 2 years' experience in clinical trial management as a CM • Experience in coaching/mentoring other CMs • Is a resource for other CMs and seeks opportunities to share knowledge base • Participates in corporate initiatives and process to ensure the continual success of Premier Research • Leads larger, more comple
Experience Required
Previous CTL experience