Clinical Program Scientist

Job Description

• 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. 

Qualifications

• Bachelor’s degree or nursing qualification is required.

• Scientific/health care field preferred, but not required.

• Experience (2+ years) working in clinical research within a pharmaceutical company or CRO or similar organization.

Key Skills, Abilities, and Competencies- 

• Strong knowledge of applicable computer and project management software packages.

• Familiarity with project management software or tools.

• Familiarity with financial budgeting and forecasting or reporting.

• Requires strong attention to detail and the ability to establish priorities, schedule, and meet deadlines. 

• Ability to work successfully within a cross-functional team and a matrix organization.

• Excellent written and oral communication skills.

• Ability to interact with investigators, vendors, and internal colleagues.

• Knowledge of current regulatory requirements and guidelines governing clinical research. 

Complexity and Problem Solving-

• Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints. 

• Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands. 

• Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner. 

Additional Information

With Regards

Ricky Bansal

732-429-1925