Shire Clinical Project Manager in Lexington, Massachusetts
The Clinical Project Manager will manage or assist 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 the study(ies).
Leads and/or assists the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline.
May assist in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors.
Contributes to the clinical review of CRFs, completion guidelines, and the data review plan
Leads/assists in 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.
Develops and monitors budget for clinical study (investigational sites and vendors).
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.
Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans.
Provide status reports to the Global Clinical Operations Lead (GCOL).
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 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.
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/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/escalate problems in a timely manner.
Education and Experience Requirements:
Bachelor’s degree 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.
Other Job Requirements:
Available for up to 25% domestic and/or international travel.
Notice to Employment / Recruitment Agents:
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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, gender identity, 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.