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Scientific. Clinical. Software Engineering

Senior Clinical Trial Manager

New Jersey All, NJ

Job Type: Clinical Job Number: JN -052020-26825 Region: New Jersey All

Job Description

The Senior CTM will manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met. The incumbent will manage study-related service providers and serve as the primary point of contact for contracted CROs, study staff and contract labs as appropriate; identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate. The Sr CTM may also be called upon to help mentor or guide less-senior staff.


Partners with Sourcing department in RFP process, identifies scope of work, study contracting needs, CRO selection process, provides input into vendor management plan, reviews quality metrics and shares lessons learned

Manages and executes vendor kick off meetings, face-to-face meetings, team training, and trial webex as required for trial execution

Reviews and oversees the development, review and operational aspects of site investigator grant and grant payment in accordance with sponsor process requirements

Tracks and obtains necessary approvals related to vendor contract change orders

Provides operational review and content to the study protocol and coordinates completion of QC review of the protocol

Leads and/or supports clinical operational team meetings in support of the respective clinical trial including: drafting agenda, collect minutes, filing minutes in the TMF, tracking action items, providing ongoing status of trial enrollment and timelines, outlining vendor related deliverables, communicating risk/issues, and managing input from other internal and external partners

Coordinates and manages investigator meetings including development of the agenda, management of slide development and review, coordination of meeting planner activities, and presenting at investigator meeting

Conducts thorough review of key specification documents related to the trial and oversees/participates in the UAT for IWR, EDC, eDiary and other systems

Provides content for study related systems and portals

Serves as the clinical operations representative on team meetings held by other functions and provides necessary input into key process related documents

Approves study invoices related to trial vendors

Provides input into and/or develops study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and approval for site receipt of study drug

Performs and/or coordinates designees in processes related to designees monitoring report review, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered

Coordinates the CROs on site selection, IRB submissions, site initiation and close-out planning

Tracks patient recruitment and progress to study timelines; supports site receipt of safety reporting; maintains and reports metrics for clinical study and CRO delivery performance

Performs and/or oversees site monitoring visits for clinical trials as needed including and not limited to ensuring clinical supplies accountability records are maintained

Provides oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with company SOPs

Provides input and support for trial site maintenance of appropriate documentation for adverse event safety monitoring

Supports QA and regulatory agency activities related to trial related audits pertaining to clinical executions (e.g. sites, TMF, etc.) including coordination of responses/corrective actions related to audit findings


Bachelor's degree in health or biologic science (BS/BA/BScN); masters-level degree is preferred

Minimum of 5 years of clinical project management experience in the biopharmaceutical industry

Strong CRO oversight and operational management skills with proven attention to detail

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