Job Description
The Associate Manager, Clinical Recruitment is responsible for planning, coordinating, and implementing patient recruitment and retention operational plans and/or patient recruitment vendors on assigned Pharmaceuticals studies. The Associate Manager, Clinical Recruitment collaborates with internal human resources and external providers to ensure alignment on recruitment/retention tactical plans, KPIs, and reporting. This role also facilitates the MLR material review process for Clinical Recruitment materials. The MLR review process requires close collaboration with the clinical teams, MLR members, and external vendors to ensure successful coordination of all patient recruitment/retention material submissions.
MLR Material Submissions
- Works cross-functionally to ensure materials meet basic approval objectives prior to MLR submission. Monitors progress, identifies risks and proposes solutions/improvements
- Prepares materials and provides support for applicable meetings, audits/inspections, and other related activity
- Initiates and/or implements internal or client procedures, processes or programs that result in continuous improvements for material review and business requirements
- Ensures that change control processes are followed to maintain accuracy of change during versioning of documents
- Supports the preparation of domestic and/or international materials for submission to MLR and prepares materials for subsequent regulatory submission and/or translations
- Updates designated databases/internal sites containing department information according to SOPs
- Compiles department metrics; prepares summary reports for department management and designated stakeholders
- Attends MLR meetings to support department activities and ensures applicable study team designee is available for MLR meeting
- Performs quality check of materials for regulatory compliance
Patient Recruitment/Enrollment/Retention Tactical Support
Support identification, selection and management of external patient recruitment vendor partners in completion of the scope of work, objectives, quality of deliverables, and other activities of projects as deemed necessary
- Coordinate and track project activities and resources to ensure that project deliverables and milestones are met
- Support content development and present materials during internal and external meetings as requested
- Communicate with sites regarding Recruitment, Enrollment and Retention activities, including but not limited to making follow-up calls regarding patient referrals, tracking logs, processing of Recruitment and Retention materials, etc.
- May represent Patient Recruitment and Enrollment with sites on the conduct of centralized Recruitment, Enrollment and Retention efforts (e.g. follow up with sites for missing documents, answer site questions, conduct Recruitment and Retention teleconferences with sites, coordinate support team activities etc.)
- Maintain data tracking entries into designated tracking systems and tools in accordance with project requirements
- Coordinate cross-functional activities in support of recruitment and enrollment goals
- Support development and implementation of Center of Excellence for Recruitment and Enrollment as well as process efficiencies associated with those activities
- Ensure all patient recruitment and retention tools are processed through internal review and internal approvals are submitted for ethics review
- Manage tracking patient recruitment and retention materials to ensure the current approved versions are available in the shared drive for team members
- Provide Management with periodic report generation and review
- Other duties as assigned by Management
- This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice
Education and Qualifications
- 5+ years of experience in the pharmaceutical/biotechnology industry
- Strong understanding of industry practice, scientific principles and regulatory/quality systems in the drug development process.
- Experience with contracting activities and managing vendors
- Experience in process development/management
- Experience working on process improvement initiatives
- Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
- Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members and direct reports
- Understanding of FDA and ICH regulations
- Ability to work effectively within a team matrix as well as independently
- Some travel may be required
- Minimum BA/BS preferably in a scientific or health-related discipline or equivalent combination of education, training, and/or commensurate experience in the clinical research industry