Manager, Clinical Operations
Proclinical is currently recruiting for Manager of Clinical Operations for a pharmaceutical company located in Boston, MA. Successful candidate will lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
- Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
- Provide leadership and input into global subject/patient recruitment plans.
- Effectively communicate and interact with Key Opinion Leaders.
- Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day to day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor.
- Manage strategic study operations including: study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
- Participate in Case Report Form design, user acceptance testing in partnership with data management.
- Generate country specific Informed Consent Form(s).
- Lead the development of contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies.
- Provide support to clinical trial managers within and/or across programs.
- Budgets, timelines, and forecasts preparation for clinical studies.
- Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, Medical Affairs; which may include lading sub-teams and/or acting as a liaison between groups.
- Provide a variance analysis of budget to actual and notifies finance of projected cost over/under expenditure.
Skills and Requirements:
- BA/BS required. MA/MS or PhD in a scientific and/or business/finance discipline is preferred.
- 6+ years of clinical research experience gained with a CRO or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies. Experience in rare diseases and/or difficult to recruit patient populations preferred.
- 2-4+ years' clinical project management experience with global clinical studies.
- Strong regulatory knowledge, including Good Clinical Practices (GCPs)
- Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
- Excellent communication (written and verbal) and presentation skills along with leadership qualities.
- Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
- Apply project management best practices to programs. Experience in novel clinical drug development.
- Experience with protocol, ICF, CRF, CSR development and review.
- Strong organizational skills and ability to deal with competing priorities.
- Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Miles Tobin at (+1) 617-545-5922 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.