Director, Clinical Documentation and TMF - Waltham, United States - Apellis

Description

Job Description

Position Summary:

The Director Trial Master File (TMF) and Clinical Documentation spearheads the vision and strategy for records management of clinical trial documents. They are accountable for leadership of the TMF organization, including technology and systems, TMF Operations, TMF inspection readiness, outsourcing and vendor governance. In this pivotal role, Director TMF and Clinical Documentation is responsible for optimizing the operating model for TMF and other clinical documentation systems. They will oversee the processes and manage the staff responsible for processing, assessing quality, and archiving of clinical trial documents from both external and internal sources, while fostering a culture of continuous improvement.

Key Responsibilities Include:

• Develop and implement innovative strategies to enhance TMF and other clinical trial documentation systems and processes, leverage technology and ensure seamless operations.
• Provide functional leadership and strategic direction to the TMF team, guiding them towards operational excellence.
• Ensure TMF compliance with industry standards and regulations.
• Oversee clinical trial document quality control activities to ensure that study TMFs are inspection ready.
• Ensure departmental and study level TMF metrics are met. Review quality control activity reports to identify trends to ensure quality.
• Lead, mentor and develop a high-performing team of TMF professionals.
• Identify and implement process improvements to elevate TMF capabilities and standards and establish necessary procedures.
• Build strategic relationships with external collaborators and vendors, establishing clear performance metrics and risk identification and mitigation strategies to ensure deliverables are met.
• Establish governance forums with key stakeholders including service providers to facilitate communication, alignment and escalation as necessary.
• Develop and forecast functional and study level budgets, ensuring minimal budget variance between plan versus actual spend.
• Provide expert support during audits and inspections.
• Foster effective relationships with stakeholder functions to achieve TMF objectives and serve as a subject matter expert on TMF across all functions involved in clinical trial execution.
• Provide direction for internal systems used for clinical trial documents and collaboration sites.
• Champion a culture of continuous improvement and lead change initiatives.
• Stay abreast of industry and regulatory standards and GCP requirements related to TMF and provide strategic guidance.
• 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.
• Undertake additional assignments and stretch projects to support operational excellence in clinical trial execution and compliance.

Education, Registration & Certification:

• Bachelor's degree in a science related field; advanced degree preferred.

Experience:

• At least 12 years prior experience in industry, with at least 6 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.
• Previous exposure to regulatory inspections.
• Experience with additional clinical systems such as Clinical Trial Management System (CTMS) preferred.
• Advanced proficiency with Microsoft Windows, Word, Excel, and PowerPoint.

Skills, Knowledge & Abilities:

• Expert knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines and regulatory requirements.
• Expert knowledge of clinical trial documentation, TMF Reference Model structure, and clinical trial activities and related terminology.
• Strategic thinker who can translate vision into actionable plans.
• Ability to analyze complex situations and provide strategic recommendations.
• Be able to innovate, initiate change, and problem-solve creatively.
• 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.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel expected.

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 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 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.