Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.
At INC Research we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.
We are currently seeking a Head of TMF to be based in either USA or Europe.
A brief summary of duties you will be involved in are:
The Trial Master File (TMF) Process Owner, Regulatory Records Management monitors and manages overall performance of TMF build and certification process to drive quality and compliance across the organization. The Process Owner is the single point of accountability for TMF quality, compliance, and inspection readiness at the organization-wide level and retains decision-making authority for overall TMF build and certification processes. This role retains global authority and oversight of any official company TMF and sponsors and leads the TMF certification process. Additionally, this role oversees the creation maintenance and revision of the official TMF structure and approves changes or additions. Moreover, the Process Owner, in collaboration with Regulatory Records Management, determines retention periods for records making up the official TMF. This role is accountable to inspection readiness leaders in all therapeutic and functional business units This role will drive the transition of the adopted certification process into a quality-by-design process. This includes: ensuring the development and execution of all CAPA commitments for assigned process and driving the end-to-end process redesign of existing processes / systems / controls to ensure that quality is built-in and to enable breakthrough performance
· BA/BS required, advanced degree with scientific or health-care training preferred and minimum of 15 years professional pharmaceutical development experience, with a minimum of 8 years leadership experience.
· Experienced in industry with expertise in the areas of clinical operations development and strategic planning; experienced with early to late stage clinical trials,.
· Able to manage clinical operations for a product from pre-clinical through all clinical phases
· Demonstrated leadership in a clinical operations role, effective organizational skills, and excellent verbal and written communication.
· Willingness and ability to travel domestically and international as required.
· Experience developing, implementing and leading a broad range of clinical trials both in the U.S. and ex-U.S., building clinical operations infrastructure, including SOPs, and managing vendors.
· Experience with Clinical Operations line management, and mentoring and developing personnel.
· Extensive experience managing contracts (vendor and site) and clinical finance activities.
· Excellent working knowledge of FDA & ICH/GCP regulations and guidelines.
· Ability to execute and follow-through to completion and documentation.
· Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
· Independently motivated, detail oriented and good problem solving ability.
· Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
· Excellent communication skills and ability to influence across multiple functions.