Location: New York, NY
CLINICAL TRIAL MANAGER
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders.
The Axsome team is comprised of a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders.
Axsome is based in New York City, New York.
The CTM is the primary operational contact for the study and leads the cross-functional team for execution of the study. The CTM provides strategic and operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the program director when needed.
- Responsible for all operational aspects and progress of clinical trial from study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicators
- Serves as an escalation point and resource for study team and investigational sites
- Oversees/facilitates site feasibility/selection processes
- Develops/oversees subject recruitment/retention strategy and related initiatives
- Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Clinical Study Report (CSR) development, etc.
- Oversees and leads field CRA team, including creation of the Clinical Monitoring Plan and ongoing review of visit trip reports.
- Responsible for oversight of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate
- Responsible for and participates in clinical vendor selection process as a part of outsourcing activities. Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations)
- Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
- Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct
- Creates, manages, measures, and reports timelines for milestone deliverables
- Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders
- Oversees internal team meetings, investigator meetings, and other trial- specific meetings
- Participates in the development, review, and implementation of departmental SOPs, initiatives and processes
- Reviews/approves vendor invoices for all clinical trial vendors including investigative sites
- Perform other work-related duties as assigned
- Bachelor degree required. Preference to candidates with a scientific background (RN, MS, PhD or similar).
- At least 5 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO). Preference to candidates with prior small company experience and 1+ years management experience.
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required
- Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results
- Strong attention to detail and excellent organizational skills
- Strong interpersonal skills and communication skills (both written and oral)
- Ability to problem solve, delegate appropriate tasks and/or mentor junior team members
- Excellent sense of urgency to deliver at/surpass study conduct targets
- Strong leadership skills, self-motivated, adaptable to a dynamic environment
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Preference to energetic candidates with a desire to think “outside the box”.
- Willingness to travel as needed, up to 20%.