Clinical Project Manager(Locals only for F2F)

Location: Lexington, MA
Date Posted: 08-04-2017
Clinical Project Manager(Locals only for F2F)
Lexington MA
Duration: 6+ months
Responsible for the planning, implementation, execution and management of one or more complex clinical research studies.
Manages clinical outsourcing to CROs and other vendors such as IRT, central and specialty labs, etc.
May author, review and approve various study related documents and plans.
Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required.
Leads cross-functional team and is responsible for the financial management of the study(ies).
Job Function and Description
Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline
Authors/contributes to clinical study documents.
Reviews and approves study related plans generated by Clinical CROs and vendors
Provides input as the subject matter expert for the study during regulatory inspections.
Responsible for the clinical review and/or approval of CRFs, completion guidelines and the data review plan
Responsible for oversight of identification and selection of investigator sites.
Responsible for planning and conducting investigators meetings.
Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team.
Collaborates with the cross-functional team on selection and management of clinical vendors.
Liaises and coordinates with document specialists regarding study files.
Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
Trains and manages CRO and other clinical vendor activities to ensure the quality meets Shire and regulatory requirements.
Monitors the status of clinical data collection of assigned clinical studies.
May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.
Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact.
Responsible for maintaining tracking information in the clinical trial management system, confirming resolution of data quality issues with the CRO.
Reviews correspondence and monitoring reports relating to the study.
Evaluates CRO and vendor performance for future work.
Provides periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Programs Lead (CPL) as requested.
Develops and monitors budget for clinical study, and reviews budgets and contracts with CROs, vendors, and investigative sites (as applicable).
Requests and critically evaluates proposals and change orders from CROs and vendors.
Leads team through selection process and provides input into contracts, change orders, and/or work orders.
Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
Supports department initiatives and process improvements.
May mentor other Study Managers.
Education and Experience Requirements
Bachelors degree is required. Scientific/health care field preferred, but not required.
Experience (5+ years) working in clinical research within a pharmaceutical company

Kiran Kumar
Key Business Solutions, Inc.
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