Manager, Trial Master File (TMF) Operations, Oncology at Eisai in Woodcliff Lake, New Jersey

Job Description:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Job Summary

The Manager, TMF Operations is responsible for collaboration with OBG Clinical Operations colleagues, cross-functional study team members and external CRO stakeholders to ensure timely and effective eTMF management, audit & regulatory inspection readiness and compliance with applicable laws and regulations.

TheManager, TMF Operationswill be required to work collaboratively with Eisai colleagues and external partners and contribute to positive team interactions across Eisai Network regions.

Essential Functions

• Oversight and management of end-to-end activities to ensure OBG study eTMFs are of the highest quality, audit & inspection ready and meet all applicable regulations and guidelines


• Active engagement and communication with Eisai functions and CRO stakeholders to ensure awareness of requirements, interpret metrics and drive timely TMF management


• Collaboration and liaison with Eisai's central TMF Management function on TMF business processes, including continuous improvement activities, training and metrics

Requirements

• 5 years pharma experience (may include CRO / Vendor experience), may include demonstrated experience in the pharmaceutical industry, in Document Management, TMF Management or Clinical Development/Operations, with in-depth knowledge and experience of eTMF process and clinical documentation


• Education to B.Sc. level or equivalent


• Proven experience with Electronic Clinical Document Management and eTMF systems and knowledge of eTMF requirements and technologies to support document collection and archiving


• Knowledge of international regulatory requirements (particularly ICH GCP guidelines) and detailed understanding of the scope and specificities of documents generated from global clinical trials


• Knowledge and understanding of the DIA TMF Reference model


• Must have broad understanding of the clinical development process


• Must have excellent verbal, written and interpersonal communication skills, to effectively collaborate with cross-functional and global teams


• Ability to drive and execute cross-functional projects with conflicting priorities


• Experience in interpreting and communicating KPI metrics and eTMF system reports for study team members and functional leadership


• Must possess excellent organizational and time management skills


• Ability to work both independently and as part of a team within a matrix environment


• Must have strong analytical and problem-solving skills


• Proficient in the use of information technology, especially eTMF and Electronic Document Management systems

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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