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Posted: Tuesday, January 16, 2018 12:06 AM

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Sr. Clinical Study Manager

Description

Duties:

Responsible for operational study strategy and study management execution, in addition to managing direct reports.
Develop project based cross-functional, integrated study plans to study start up (in-house), and validate and manage the overall study implementation plan provided by the CRO. Participate in site selection and site qualification with study team and CRO
Lead the Study team along with contributing to operational delivery aspects of the protocol and lead document review & coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.
Ensure meeting logistics, agenda and minutes are in accordance with internal standards.
Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders to ensure cross functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc.) per the study plan.
Oversee the CRO and provide timely input to ensure that the CRO-generated documents are created in a timely manner (communication plan, site monitoring plan, etc.) ahead of study start.
Oversee CRO study start-up activities and coordinate with functional group to ensure that essential site documents are collected and sites are initiated per plan.
Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.
Management of vendors is not limited to the CRO, but includes ancillary vendors (e.g. translations, trial insurance, and central laboratory).
Work closely and oversee CRO activities for study execution with CRO on a task and operational level per the project plan. Oversee CRF completion and monitoring; Triage, resolve or escalate study issues to the supervisor.
Oversee CRO study close-out. Liaise with internal functions to ensure drug destruction process is implemented. Liaise with CRO to support database lock and review of TLG before and after database lock.
Confirm internal tracking systems are updated (e.g. Global Project Management System, GPMS).
Ensure the delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
Focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and objectives set forth by the Study team.

Skills:

A Nursing diploma or Associates degree required; A Bachelor’s or Master's degree in a Scientific field preferred
5+ years relevant experience managing a study team; 2+ years experience working with Oncology studies required
Knowledge of Phase Ib/II/III Oncology trial experience a must
Global trial experience strongly preferred
Global Study Leadership of Pivotal NDA filing studies highly preferred
PMP or CCRA certifications desired
Experience working in both sponsor and CRO organizations strongly preferred
Relevant experience includes Clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.

***For immediate consideration, please email your updated resume to Apex Life Sciences at kschott@apexlifesciences.com with "Clinical Study Manager" in the subject line.

• Location: Bernards, NJ, Central Jersey

• Post ID: 50500712 centraljersey
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