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Regional Director of Operations

Company: Biotech, Andover, MA
Location: Andover
Posted on: June 19, 2018

Job Description:

Job Description

The Regional Operations Director, Clinical Operations, has responsibility for all Company sponsored clinical trials for the US region. Additionally, the Regional Operations Director, Clinical Operations will have responsibility for assigned global trials that have a significant number of US sites. In support of corporate functions, the Regional Operations Director, Clinical Operations collaborates with senior management in the Global Clinical Operations department in developing clinical strategies to ensure implementation of key organizational objectives and clinical programs. The Regional Operations Director functions with minimal supervision, collaborating with inter- and intra-company resources to ensure quality performance and that corporate timelines and needs are being met. Assignments include oversight and line management of Clinical Study Managers, dotted line oversight of Clinical Research Associates, and Clinical Trial Assistants, clinical program management, development team leadership, SOP development, protocol development, resource allocation, hiring, contracting, and supervision of clinical operations roles, CROs and leadership of GCP training programs. The Regional Operations Director, Clinical Operations, is responsible for training and mentoring direct reports and for their career development by assisting in the creation and implementation of individual development plans. The position reports to the VP, Global Clinical Operations.

Summary of Essential Job Functions Provide oversight of multiple clinical programs and evaluate and oversee the activities required to execute, conduct and complete a program, within established timelines and corporate budgets. Provide strategic input into the development of the clinical trial protocols for to ensure clinical designs are implementable to efficiently achieve the objectives. Provide strategic input in the development of protocols, CRFs, ICFs, Monitoring Plans, Investigator Brochures, clinical study reports and publications related to the clinical trials. Identify and evaluate potential clinical partners which may include CROs, investigators, and other vendors necessary to execute the clinical program. Collaborate with cross-functional team members (e.g., pre-clinical, manufacturing, data management, safety surveillance, biostatistics, Regulatory Affairs, and Quality Assurance). Oversee the creation and negotiation activities for clinical trial budgets and Clinical Trial Agreements; assist with contract negotiations with vendors. Develop, implement and ensure adherence to study timelines, program objectives and monitoring plans. Manage and report on study budgets to include addressing variances, payments and revisions, as applicable. Review, track and report staff performance utilizing appropriate tools and reports. Function as liaison for key clinical investigators and internal Company personnel in regards to clinical related topics and/or questions. Support the development of clinical operations related Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable. Track, measure and report the status of program milestones. Assist in the analysis and reporting of study data (e.g., tables, listings, clinical summary reports, regulatory submission, publications and presentations). Assist in the development and implementation of clinical research strategy and manage clinical processes to ensure business goals are met. Assist with assembly and review of documents for regulatory submissions. Collaboration on the development of clinical SOPs, Work Practice Guidelines (WPGs) and associated tools. Periodically review SOPs, WPGs and associated tools for applicability and suggest appropriate modifications. Develop and periodically evaluate job descriptions for assigned staff. Develop, implement and evaluate direct reports orientation and ongoing training. The training may include position specific training and therapeutic training. Ensure clinical operations teams regulatory and Good Clinical Practice (GCP) compliance. Comply with applicable regulations, GCP and corporate policies and procedures. Qualifications : Master’s Degree (or equivalent education and experience) from an accredited College or University in pharmacy, biological sciences, chemistry, or other appropriate scientific/technical discipline. A minimum of 10 years of applicable experience, in device, biologic or pharmaceutical development, with progressive responsibility including managerial responsibility. Previous study management or project management experience at a sponsor or CRO preferred. Abilities Required Ability to assess the inherent risks of a situation, their potential impact on a project and based on this information, independently make timely decisions. Capable of formulating a clinical project plan based upon literature, input from internal and external experts, and own experience. Must have a demonstrated ability to guide programs having major division/staff importance to successful completion with minimal direction. Ability to manage vendor/contracts relationships. Strong GCP and regulatory knowledge including ISO, FDA and ICH regulations. Working knowledge and experience with Word, PowerPoint and Excel. Must be able to travel up to 40%. Strategic thinking capability and strong with decision-making

Keywords: Biotech, Andover, MA, Attleboro, Regional Director of Operations, Executive, Andover, Massachusetts

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