Shire Clinical Research Associate Manager in Cambridge, Massachusetts
Under supervision of the Head of Clinical Study Support, manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include hiring FTEs and contractors, planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
Liaise with Head of Clinical Study Support and/or Global Clinical Operations Leads to ensure allocation of CRA staff are aligned with department priorities.
Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies/programs that are appropriate to their experience and training.
Identify and ensure all necessary training is provided to CRAs on an ongoing basis to optimize job performance and knowledge of Shire procedures, ICH-GCP and other local regulations.
Demonstrate leadership to direct reports, ensuring employees adhere to corporate policies and following up with management as appropriate.
Monitor and evaluate assigned CRA workloads ensuring timely completion of project deliverables as requested by the Clinical Program Managers.
Ensure compliance with pre-defined roles and responsibilities matrix for the management of CRAs.
Serve as an ongoing liaison with the relevant clinical study teams, and provide feedback regarding corporate goals and objectives as well as performance of direct reports.
Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the teams and stakeholders in an open, balanced and objective manner.
Directly support Clinical Program Manager(s) with regards to
Study Start-Up Activities:
Lead Clinical Operational Excellence & Support service Plan meetings and assists the study team(s) to ensure CRO Scope of Work is in alignment with the study oversight necessity.
Provides clinical study start up expertise and ensures identified efficiencies within study start-up are implemented.
Assists in providing oversight of CRO for site identification and selection activities..
Provides oversight of Clinical CRO activities regarding Legal review/negotiation/execution of confidentiality and site agreements.
Provides oversight of Clinical CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval.
Ensures effective communication between Shire and the Clinical CRO.
Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.
Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.
Assists and/or participates in planning and conduct of Investigator’s Meetings as necessary.
Study Maintenance & Close out Activities ( as Necessary ):
Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced.
Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager.
Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.
Assists study team with preparation for audits/inspections
Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager.
Liaises with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly.
Departmental and Process Related Tasks:
Maintains knowledge and acts as team super user or subject matter expert for Shire systems and processes.
Support department wide process training and awareness initiatives
Participates in inter-departmental workgroups to create or enhance processes.
Maintains up to date training record attending internal/external training(s) as necessary.
Education and Experience Requirements
Bachelor's degree required (Advanced degree or certification prefered but not required)
Minimum 5 year's experience in relevant role (eg. Sponsor, CRO or Clincal Study Vendor)
Prior experience in line management and/or experience as a mentor/coach to staff members
Other Job Requirements
- Minimal travel may be required
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.