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Senior Clinical Study Manager

New Jersey All, NJ

Posted: 11/06/2018 Job Type: Clinical Job Number: JN -112018-22989

Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams.

Responsibilities involve a combination of execution and oversight dependent on the sourcing model to ensure deliverables and may include, but are not limited to, the following:

Financial Planning and Management:
Development/management/reconciliation of overall study budget(s)
Development/management of vendor scope of work (SOW) per contract, quality, and budget
Review/approval of vendor invoices and management of accruals and SOW changes

Project Management:
Oversight of study execution utilizing available performance metrics and quality indicators
Oversight of clinical monitoring quality and adherence to established processes and plans
Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
Maintenance/updating of data as appropriate in project management tools including CTMS
Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation

Study Planning and Conduct:
Facilitation of country and site feasibility/selection processes
Operational input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
Oversight of investigational product [IP]supply forecasting/management and study-level IP reconciliation [in collaboration with IMSC]
Development of the subject recruitment/retention strategy and related initiatives
Participation in clinical service provider (vendor) selection, specification development, and management/oversight
Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance
Development/coordination of study training for study team, investigational sites, and vendors
Oversight of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications
Participation in Serious Adverse Event (SAE)reconciliation process
Experience with data cleaning and database closure coordination.

Essential Experience Required:
Minimum 6 years of global clinical study management experience at a CRO or Pharma/Biotech, with at least 3 years of recent Hematology/Oncology studies, and 3 years of CRO oversight experience

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