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