Supervisor: Vice President, Clinical & Regulatory Services
Job Function: The CRM will independently manage clinical research activities for Emerson Consultants, Inc. clients. The CRM will manage both pre-market and post-market clinical research activites in support of client’s products and therapies. The CRM will facilitate the direction, planning, development, conduct, and analysis of clinical studies.
Description of Duties: Performs the following tasks independently:
- Develop clinical strategy in consultation with client to achieve client’s objectives
- Determine study objectives, strategy, scope and schedule in order to meet client’s needs
- Develop a clinical study design and clinical protocol consistent with the agreed upon clinical strategy, and in compliance with all applicable regulations and Standard Operating Procedures. Develop the Investigational Plan/protocol in consultation with the cross-functional clinical project team, and investigators
- Work collaboratively with Regulatory Affairs to meet any regulatory requirements for the study. Participate in preparation of clinical materials for meetings with regulatory agencies. Participate in meetings with regulatory agencies as required
- Work collaboratively with Reimbursement to meet any payer requirements for the study. Participate in preparation of clinical materials for meetings with payers. Participate in meetings with reimbursement agencies as required
- Develop a detailed clinical study project plan and budget, and be accountable to the client’s management for achieving the project milestones, and managing the study within the agreed upon budget and timelines
- Lead a cross-functional clinical project team for each assigned study to ensure effective communication among all internal and external study staff
- Assist with supervision and assignment of tasks to members of the clinical project team with direct responsibility for implementation of the study. Enlist support and specify tasks for various clinical team members to assure meeting study objectives on schedule.
- Manage clinical study site relationships, ensure effective and timely communication with sites and investigators; troubleshoot and make recommendations to optimize site compliance and satisfaction with all aspects of clinical study implementation
- Select and manage the activities of any vendors involved in the implementation of the clinical study
- Write clinical reports for submission to regulatory agencies or investigators as appropriate. Evaluate clinical data/information, providing interim and final reports, convening and directing investigator conferences to review findings and advise on direction
- Assist investigators with preparation of manuscripts for publication of study results
- Troubleshoot all aspects of clinical study operations, and provide timely feedback and recommendations to clients to ensure successful implementation of assigned studies
- Other responsibilities as assigned
- Position may require up to 30% travel
Education, Training and Experience Required:
- Bachelor’s degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field
- Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience
- More than five years experience directly supporting clinical research or similar experience in a medical/scientific area
- High attention to detail and accuracy
- Self-directed individual, able to take the initiative and handle ambiguity
- Advanced written and oral communications skills
- Able to manage multiple tasks
- Proficient knowledge of medical terminology
- Expertise with GCPs and regulatory compliance guidelines for clinical trials
- Good problem-solving skills
- Knowledge of clinical and outcomes research designs and methods