Associate Director, TMF

Position Summary:

The Trial Master File (TMF) Associate Director is responsible for assisting in the creation of the vision and plan for establishing a records management strategy for clinical trial documents in a hybrid/federate operating model. They oversee the process and manages the staff responsible for processing, assessing quality, and archiving of clinical trial documents from both external and internal sources. The TMF Associate Director is also responsible for the oversight of the development, maintenance, and enhancement of clinical documentation systems such as the electronic Trial Master File (eTMF) system and electronic resource and collaboration sites. The TMF Associate Director participates in the identification, evaluation, and implementation of appropriate technology and vendors to support solutions and requirements for the changing landscape of the TMF and other computerized documentation systems. The TMF Associate Director, or named GCP Archivist, oversees management of correct archiving procedures within Apellis in accordance with company policies, operating procedures, GCP, federal policies and any other contractual obligation.

Key Responsibilities Include:

• Meet departmental and project productivity and quality metrics and provides TMF financial and management accountability
• Participate in creating the near- and long-term vision for clinical support to include capability planning, budget planning and vendor assessment
• Manage external vendors with input from stakeholders. Oversee development and approval of change orders, and payments
• Oversee and manage Clinical Support staff to ensure quality, compliance, and inspection readiness
• Manage performance, development, and growth of Clinical Support staff; support and guide them to improve efficiency, effectiveness, prioritization, and problem solving
• Ensure systems are in place to identify and track content inventory of clinical trial documents
• Provide direction for internal systems used for clinical trial documents
• Serve as subject matter expert for TMF system and electronic resource and collaboration sites
• Work in partnership with stakeholders including IT R&D Systems, Clinical Quality Assurance, Operational Excellence
• Collaborate effectively with internal functional areas and external vendors including clinical service providers and create and maintain governance documentation, as necessary
• Provide oversight of internal functional areas and external vendors including clinical service providers (CSPs) by tracking performance and providing documentation for identifying issues (trends) and determining remediation
• Serve as point person for clinical study team escalation
• Establish project plans, including production of detailed tasks, milestones, and timelines
• Oversee clinical trial document quality control activities to ensure that study TMFs are inspection ready
• Review quality control activity reports to identify trends to ensure quality
• Identify and implement process improvements and establish necessary procedures
• Author standard operating procedures, work instructions, job aids, templates, and forms
• Create an archiving strategy for clinical trial documents and provide oversight of archiving activities according to industry best practices

Education, Registration & Certification:

• Bachelor’s degree

Experience:

• At least 10 years prior experience in industry, with at least 5 years in TMF management
• Experience managing and mentoring staff
• Extensive knowledge of Study, Country, and Site level essential clinical trial documents and knowledge and understanding of the clinical trial process and GCP/ICH guidelines
• At least 3-4 years of experience with Veeva Vault Clinical (eTMF) system
• Advanced proficiency with Microsoft Windows, Word, Excel, and PowerPoint
• Demonstrate clear alignment with Apellis Core Values as well as Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture, and Passion for Excellence

Skills, Knowledge & Abilities:

• Expert knowledge and application of ALCOA standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (E6(R2))
• Expert knowledge of clinical trial documentation, TMF Reference Model structure, and clinical trial activities and related terminology
• Detail-oriented with strong organizational abilities with an ability to multi-task, be flexible, and thrive in a fast-paced team environment
• Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.