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.

The Senior Associate, TMF Management, is responsible for performing global management activities relating to electronic and paper Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.

Functions may include, but not limited too; eTMF system set-up and maintenance, creation/management of TMF Plan and filing expectations; eTMF query resolution, eTMF user support, and assisting with the oversight of the eTMF vendor; performing quality control reviews of eTMFs to ensure they adhere to SOPs and meet regulatory requirements and ICH guidelines.
This role will be required to work collaboratively across functional areas and contribute to positive team relationships, both locally and globally.

The Senior Associate, TMF Management, will serve as a subject matter expert in TMF Operations.

Essential Functions

• Manage assigned studies; create and maintain the TMF Plan and TMF Index, monitor document submissions and query workflows and delivery monthly Health reports/CRO metrics / Key Performance Indicators, along with strategy / summary of way to improve. 25%

• Manage activities within electronic TMF Management system including: Study set-up,  milestones/events, oversee and monitor the completion of study / country / site Completeness reviews, trigger Archival activities at the study close, perform ad hoc system trainings and demos as required for assigned study teams and/or CRO Partners.  25%

• Trigger and manage the activities related to archiving of TMF documents, including obtaining approval from the study team, notifying the Eisai Archivist, and maintaining electronic logs which contain the location of study documents. 10%

• Oversee the TMF Completeness activities associated with reviews / updates to the EDLs to ensure adherence to SOPS and regulatory requirements. Assist with generating various reports, metrics and analyzing trends across studies, countries and sites. 20%

• Oversee the project teams to ensure the Eisai study team and outsourced CRO are compliant with eTMF Processes/Procedures and/or management for the correction and resolution of quality issues, TMF completeness and timely submission of documents to the TMF. 10%

• Assist or initiate improvements of departmental SOPs, SWPs, work guidelines or trainings as needed. 10%

Requirements

• Bachelor’s degree in scientific or technical discipline recommended with minimum of 3-4 years of pharmaceutical industry experience (8+ years of hands on TMF/document management experience will be considered in lieu of a Bachelor’s degree).

• Preferred 1-2 years of experience in TMF/eTMF, clinical document management and/or clinical quality control.

• Good understanding of clinical development, including regulatory documents and regulatory requirements (including ICH and GCP guidelines)

• Experience/ Knowledge/understanding of TMF requirements and technologies (such as PhlexEView and Veeva Vault) to support document collection and archiving; eTMF experience required

• Strong document management skills, including experience with review of Regulatory Documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines

• Good critical reasoning skills, including the identification and resolution of complex problems

• Must be proficient in MS Office

• Strong verbal, written and interpersonal communication skills

• Shows high level of initiative and has ability to work independently

• Very detailed oriented and excellent organizational and time management skills

Eisai Salary Transparency Language:

The base salary range for the Sr. Associate eTMF is from :78,300-102,800

Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

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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