Sr. Clinical Project Manager

  • Company: Shire plc
  • Location: Massachusetts, United States
  • Posted: November 01, 2017
  • Reference ID: R0013348
Primary Duties
  • 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.

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