Shire Senior Clinical Project Manager in Lexington, Massachusetts
Responsible for the planning, implementation, execution and management of one or more clinical research studies.
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.
Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required.
Responsible for the financial management of a study, and develops and oversees study timelines.
Represents and leads the study team to design, develop and deliver the clinical study to agreed upon timelines.
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.
Executes the clinical study in accordance with the project clinical development strategy and timelines.
Responsible for the clinical review and/or approval of Case Report Forms (electronic as applicable), and provides clinical input into corresponding completion guidelines.
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.
Reviews and approves study plans.
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 & Experience Requirements:
Bachelor’s degree or nursing qualification 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.
Available for up to 25% domestic and/or international travel.
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 invesigators, 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/elevate problems in a timely manner.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.