Clinical Development Manager
7 days ago
BESTMSLs is a leading company in the clinical trial industry, dedicated to providing exceptional services and expertise to our clients.
Job DescriptionWe are seeking an experienced Clinical Trial Liaison Manager to join our team. The successful candidate will be responsible for overseeing site trial delivery, subject recruitment, protocol adherence, and data quality.
This is a hybrid office-based position with regular travel in the field, based in North America. You will represent the company in site relations, support study teams with startup and recruitment, and manage in-field activities of the contracted CRO, focusing on the CRA team.
You will also address unresolved investigator concerns, engage with PIs for study updates and recruitment plans, and support local site staff and trial team members.
Responsibilities- Site and Investigator Relationship Management
- Act as an ambassador for the company, supporting its positioning as a sponsor of choice, and representing the sponsor with investigators and site staff.
- Drive enrollment at the principal investigator (PI) level, collaborating closely with clinical research associates (CRAs) and study coordinators.
- Facilitate collaboration between departments or groups within the same trial site to optimize subject enrollment.
- Maintain accountability for long-term operational partnerships with key sites, providing local intelligence.
- Lead strategic partnerships with key sites to implement collaborative initiatives for clinical trial execution.
- Oversee and track patient recruitment for sites, proactively identifying ways to prevent delays.
- Support the development of recruitment and retention plans in collaboration with Lead CSM, CSM vendor/CRO, or Local CSM.
- Conduct motivational or booster visits upon request by the sponsor.
- Report local site situations and provide insights on recruitment challenges and solutions.
- Ensure data quality and integrity meet Good Clinical Practice (GCP) standards and local regulations through data reviews (remote and onsite).
- Oversee the activities of local CRO teams to ensure effective sponsor oversight of monitoring activities.
- Conduct Sponsor Oversight Monitoring Visits (SOVs) to ensure accurate and compliant monitoring, including source data verification (SDV) as needed. Accurately create and document progress in clinical trial monitoring system and follow up on open issues through resolution.
- May attend pre-study visits (PSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs).
- Identify trial issues proactively, seek solutions, and escalate them to the appropriate authorities (Lead CSM, CSM vendor/CRO, or Local CSM).
- Collaborate with other CTLMs, Lead CSM, CSM vendor/CRO, or Local CSM to share best practices and beneficial experiences.
- Support CRAs and local CRO team members to aid trial delivery and compliance.
- May assist with quality assurance, audit and inspection preparations, including generating and implementing Corrective and Preventive Action (CAPA) plans.
- May attend audits and inspections as required.
- Adhere to company SOPs.
- Bachelor's degree required, preferably in the life/physical sciences.
- Nursing or PharmD preferred but not mandatory.
- Strong scientific background with at least five years of clinical development experience.
- Extensive clinical development and pharmaceutical experience with a good knowledge of the applicable regulations in order to have a thorough understanding of the processes associated with executing clinical development plans.
- Experience working on audits, regulatory inspections, and CAPAs.
- Experience working on Phase 1-4 clinical development studies.
- Highly desirable but not required: Experience supporting regulatory submissions, previous roles working as a CTLM, study coordinator, research nurse, or in Med Affairs Operations, formal Project Management training or certification, and working with rare diseases.
The salary for this position is estimated to be around $90,000 per year, depending on qualifications and location.
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