Trial Master File (TMF) Senior Specialist

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

Job Description:

Responsible for working in collaboration with both clini cal operations teams and functional areas outside of Global Development Operations (GDO) to successfully and proactively manage study-specific Trial Master Files (TMF), both electronic and paper in format. Responsibilities include creating and maintaining TMF governance documentation, performing quality reviews of TMFs for completeness, performing record review for accuracy and quality to achieve TMFs that are in an ongoing state of inspection readiness. in format. Responsibilities include creating and maintaining TMF governance documentation, performing quality reviews of TMFs for completeness, performing record review for accuracy and quality to achieve TMFs that are in an ongoing state of inspection readiness.

General Position Summary / Purpose:

• Provide support and guidance to clinical operations teams and functional areas outside of Global Development Operations (GDO) in the management of Trial Master Files (TMF), both electronic and paper
• Ensure adherence to PCYC's standards (policies and SOPs/WIs), and all applicable regulations and guidelines (for example FDA regulations and ICH GCP guidelines) across the management of TMFs
• Lead TMF stakeholders in the identification and mitigation of TMF inventory gaps and other TMF related issues for all assigned studies/ programs
• Identify, track, and review TMF content across multiple studies/ programs

Key Accountabilities / Core Job Responsibilities:

• Work with multi-functional study teams to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness
• Create and maintain study-specific TMF Management Plan and indices
• Manage conduct of TMF quality reviews by cross-functional study team; driving to closure quality review findings
• Support the functional owners in the identification and management of the collection of study specific TMF content, (where PCYC owned, and when delegated to vendor and/or CRO)
• Performs independently; day to day quality check of TMF content and accuracy of coding
• Acting TMF subject matter expert (SME)/ point of contact for study teams and TMF stakeholders
• Produce and manage site/ study/ business level TMF reports and metrics provide to study teams who us the eTMF as the repository of their TMF records
• Manage and reconcile TMF records across multiple record management databases
• Perform inventory activities for off-site storage records
• Provide input on the revision of TMF related Work Instructions and SOPs
• Create and provide training on CRM processes/ procedures
• Perform TMF oversight in the form of periodic risk-based quality checks on records reviewed by Clinical Records Administrators
• Provide support and TMF guidance in audits and/ or inspections
• May provide training and mentoring activities for new and current staff

Qualifications / Requirements:

• 5 plus years of Clinical Research Associate (CRA) or higher equivalent experience
• 3 plus years of relevant records management/ TMF management experience
• Exemplary interpersonal skills
• Comprehensive understanding of the clinical study phases involved in drug development and their corresponding records requirements
• Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines related to Clinical Document Management
• Demonstrated ability to apply clinical operations knowledge in the use of Clinical Information Systems
• Ability to collaborate with study teams to establish and determine their technical, functional requirements and performance requirements
• Ability to train and mentor colleagues and teams
• BA/ BS required

Equal Opportunity Employer Minorities/Women/Veterans/Disabled