Clinical Program Scientist

• Manages or assists in the planning, implementation, and execution of a clinical research study(ies). 

• Manages clinical outsourcing to CROs and other vendors such as IVRS, labs, IRBs, etc. 

• May author, review and approve various study related documents and plans. 

• Leads cross functional teams and is responsible for the oversight and management of study timelines as well as the financial management of a study.

• Leads and/or assists the study team to design, develop and deliver the clinical study to agreed upon timelines. 

• May assist in authoring/contributing to clinical study documents and study related plans developed by Clinical CRO and vendors. 

Responsibilities-

• Leads and/or assists the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines. 

• Contributes to the clinical review of Case Report Forms (electronic as applicable), data review plan, and other data management documents and corresponding completion guidelines. 

• Leads/assists in oversight of the identification and selection of investigator sites. 

• Assists and/or participates in planning and conduct of investigator’s 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 potentially 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. 

• May support or co-manage larger complex trials as necessary. 

• Leads and/or assists in the oversight of CRO activities and other clinical vendors 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. 

• Reviews clinical monitoring reports and correspondence related to monitoring visits. 

• Responsible for maintaining tracking information in the clinical trial management system and confirming resolution of data quality issues with the CRO.

• Ensures effective communication between Shire and the Clinical CRO. 

• Reviews and approves study plans. 

• Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans. 

• May provide periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Operations Lead (GCOL) as requested. 

• May develop and/or monitor budget for clinical study (investigational sites and vendors). 

• May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors. 

• Develops knowledge of therapeutic area, current medical practice and industry regulations in order to ensure best practice across all activities. 

• Supports departmental initiatives and process improvements.