Associate Manager - Contract - Armonk, NY
Drive end‑to‑end clinical trial delivery as the key support to the Clinical Study Lead in a dynamic Associate Manager role.
The Temp Associate Manager Clinical Study (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct execution versus oversight of CROs deliverables will vary accordingly.
Primary Responsibilities:
The successful candidate will work with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron Standard Operating Procedures (SOPs). Travel to study sites may be required to assist with monitoring clinical studies.
Skills & Requirements:
- Bachelor's degree in a relevant field.
- Strong experience in clinical trial management, including planning, execution, and oversight.
- Knowledge of GCP, ICH, CFR, and clinical trial regulations.
- Proficiency in managing study systems such as CTMS and TMF.
- Excellent organizational, communication, and problem-solving skills.
- Ability to collaborate effectively with internal teams and external vendors.
- Willingness to travel to study sites as needed.
The Associate Manager's responsibilities will be:
- Lead or oversee the planning and management of clinical studies in assigned regions, aligning with global study plans.
- Contribute to risk assessment and develop risk mitigation strategies.
- Support feasibility assessments to select relevant regions and countries for study execution.
- Oversee the development of study-specific documentation, including case report forms, data management plans, and monitoring plans.
- Review site-level informed consents and patient-facing study start-up materials.
- Manage study systems such as CTMS and TMF, and contribute to investigator meeting preparation and execution.
- Engage, contract, and manage required vendors for the study.
- Oversee study drug and clinical supplies forecasting, accountability, and reconciliation.
- Provide regular status reports to stakeholders and escalate issues as needed.
- Develop and implement recruitment and retention strategies, monitor progress, and address challenges.
- Ensure data quality through regular review of metrics, protocol deviations, and suspected non-compliance.
- Support audit and inspection readiness throughout the study lifecycle and contribute to CAPAs as required.
- Manage study close-out activities, including database lock, vendor contract reconciliation, study budget, TMF, and drug accountability.
- Mentor clinical trial management staff and handle unmasked tasks as required.
If you are having difficulty in applying or if you have any questions, please contact Alex Kelly at a.kelly@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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