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Senior Study Manager - Clinical Operations

Location : Bensalem PA US 19020
Job Type : Temp/Contract
Reference Code : 19170-AB1
Compensation : open - 40-55/h
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Chemistry or Life Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Contract position (at least 6 months) for Senior Clinical Study Manager to oversee assigned protocol study and operation.

  • Manage and resolve strategic study management issues within and external to the function.

  • Daily management of CRO and other vendors involved with study, including setting expectations, training, oversight, managing deadlines, and resolving issues.

  • Offers team insight for future studies including site selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings.

  • Responsible for planning and management of Trial Master File, development of informed consent, monitoring and EDC / Case Report Forms.

  • Review of study data and assisting with writing Clinical Study Reports.

  • Ensure adherence to regulatory requirements, SOPs and safety procedures.

  • Assist with improving productivity, increasing efficiencies, and cutting costs.

Required Qualifications :

  • BS Chemistry or related life science. Advanced degree preferred.

  • Minimum 5 years related experience in pharmaceutical clinical studies.

  • Self-starting, detail-oriented, data-driven, with good organization, interpersonal, problem solving and communication skills.

  • Microsoft Office proficient.

  • SharePoint proficiency is a plus.

Contact: Allan Berman

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