- 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).
- 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 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 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 Operations Lead (GCOL) 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
- Bachelor's degree is required. Scientific/health care field preferred, but not required.
- Experience (5+ 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, including Microsoft Word, Excel, Project, and Power Point
- 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 individuals at all levels of the organization.
- Working knowledge of current global 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 juggle multiple competing tasks and demands.
- Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/escalate problems in a timely manner.
Internal and External Contacts
- This job reports to Clinical Programs Team Lead and functionally accountable to the Clinical Programs Lead/GCOL.
- Internal stakeholders include the cross-functional study team and other stakeholders as identified.
- External stakeholders include counterparts at Contract Research Organizations and vendors (e.g. clinical laboratories), investigative sites, and other stakeholders as identified.