Study Manager Job

SENIOR STUDY MANAGER needed for a contract opportunity with Yoh's client located in Warren, NJ.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Clinical study management
- Financial budgeting

WHAT YOU'LL BE DOING:

The Senior Study Manager 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.

- 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
- 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 [ie 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
- 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 (eg CTA, MoH) and country/site IRB/IEC approvals/notifications
- Participation in Serious Adverse Event (SAE)reconciliation process

WHAT YOU NEED TO BRING TO THE TABLE:

- BA/BS Degree in relevant discipline.
- Minimum 6 years clinical study management experience with at least 2 years direct multinational study management experience.
- Minimum of 2 years experience in oversight of CRO study execution.
- Clinical trial project management skills.
- Financial budgeting and forecasting skills.
- Leadership/influence management skills.
- In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.
- Ability to effectively lead a global cross-functional team in a Matrix environment.
- Time management skills - ability to effectively multi-task and prioritize.
- Disease/therapeutic knowledge.
- Solid computer skills - requirement of MS Applications including (but not limited to) MS Project, Word, Excel.
- Study Tools including electronic system skills - CTMS/EDC.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

J2W: SCIENTIFIC

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