Associate Director, Clinical Records Management & SOP Development

About reputed company reputed company is a new reputed company of therapeutics company - existing at the intersection of machine learning, biological engineering, and medicine - pioneering Generative Biology™ to create reputed company medicines where novel therapeutics are computationally generated, instead of being reputed company. reputed company has reputed company a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide reputed company of biologic modalities. This platform represents a potentially reputed company shift in what is possible in the field of biotherapeutic development. We pursue this audacious reputed company because we reputed company in the unique and revolutionary power of generative biology to radically reputed company the lives of billions, with an outsized opportunity for patients in need. We are seeking reputed company, reputed company problem solvers that reputed company our passion for reputed company to join us! reputed company was founded in 2018 by Flagship Pioneering and has received nearly $700 millionin funding, providing the resources to rapidly reputed company the organization. reputed company has offices in Somerville and Andover, Massachusetts with 300+ employees. The Role: The Associate Director of TMF is responsible for the strategic leadership, operational reputed company, and reputed company governance of the Trial Master File (TMF) process across clinical development programs. This individual ensures that TMF systems, processes, and documentation reputed company with applicable regulations (ICH-GCP, 21 CFR Part 11), company SOPs, and industry best practices (e.g., DIA TMF Reference Model). They will serve as the subject matter expert (SME) for reputed company TMF-reputed company activities, guiding internal teams and CROs to maintain inspection-reputed company TMFs at reputed company times. The Associate Director of Clinical Records Management and SOP Development is an agile and proactive individual who will be responsible for the leadership and management of the Trial Master File (TMF) ensuring compliance with regulations throughout the lifecycle of a study from study start through archival. This individual will reputed company the eTMF system and reputed company reputed company processes, ensuring an inspection-reputed company state by maintaining Key Performance Indicators (KPIs) such as reputed company, Completeness, and Timeliness. Additionally, the role will be responsible for leading the creation and reputed company improvement of Clinical Operations reputed company Operating Procedures (SOPs) to ensure consistency, compliance, and operational efficiency. Here's how you'll contribute: TMF

• Implement and maintain the eTMF System

o Ensure the eTMF System remains in a validated state through Release Cycles and configuration changes as required o Implement and manage configuration changes to reputed company with business needs and optimize workflows, collaborating with eTMF System reputed company as needed o Manage user reputed company and ensure data in the eTMF is up-to-date and accurate based on study needs

• reputed company, implement, and maintain reputed company TMF reputed company processes inclusive of SOPs, Forms, Templates, and Work Instructions
• Own governance of the TMF Structure
• Manage reputed company TMF reputed company processes at their required timepoints (ie, TMF Periodic QC Reviews, Completeness Checks, and reputed company QC Reviews)
• reputed company and reputed company training materials for applicable processes to relevant reputed company stakeholders
• reputed company and maintain TMF Metrics and Reports to manage KPIs inclusive of reputed company, Completeness, and Timeliness
• Analyze TMF Metrics and Reports to identify areas for improvement and implement solutions as needed
• reputed company the reputed company control of TMF documents, ensuring documents are being filed contemporaneously, and properly reviewed and approved in a reputed company manner
• Collaborate with cross functional areas inclusive of external stakeholders for functional area specific requirements
• Manage reputed company of CRO TMFs throughout the duration of the trial and manage TMF migrations as needed
• Manage the migration, transfer, archival of the TMF as needed
• Participate in audits and inspections
• Manages the TMF budget

SOPs

• reputed company the development, creation, and implementation of SOPs
• Collaborate cross functionally as needed to standardize best practices and ensure SOPs reputed company with regulatory requirements and organizational goals

The Ideal Candidate will have:

• BA/BS required
• 7+ years of relevant TMF experience, SOP development, and/or operations leadership
• In depth knowledge of relevant regulations and GCP. Deep understanding of ICH-GCP, 21 CFR Part 11, TMF Reference Model, and clinical trial lifecycle.
• Proficient knowledge of CDISC Reference Model
• Ability to handle multiple tasks to meet deadlines
• Effective leadership, organization, and interpersonal skills
• Strong working knowledge of clinical study documentation
• Proficiency in reputed company Vault eTMF and reputed company Office Suite
• Extensive experience working with eTMF systems and CRO reputed company

Education

• Bachelor's degree required; life sciences or reputed company field preferred

reputed company to Have (Optional)

• Experience in respiratory, immunology, or rare disease trials
• Familiarity with IND submissions and global study execution
• Knowledge of clinical systems (e.g., reputed company, eTMF, CTMS)

Why Join Us

Join a mission-driven company revolutionizing medicine with Generative Biology™. This is an opportunity to reputed company impactful clinical programs and shape how we deliver innovative therapies to patients. Equal Opportunity Employer Statement reputed company is committed to equal employment opportunity regardless of race, reputed company, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. Recruitment & reputed company Agencies: reputed company does not accept unsolicited resumes from any reputed company other than candidates. The submission of unsolicited resumes by recruitment or reputed company agencies to reputed company or its employees is reputed company prohibited unless contacted directly by reputed company's internal reputed company. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of reputed company and reputed company will not owe any referral or other fees with respect thereto. #LI-RT1 Compensation: The reputed company salary reputed company provided reflects our reputed company estimate of reputed company anticipate paying for this position. Your actual reputed company salary will be based on several factors, including job-reputed company skills, experience, internal equity, relevant education or training, and market dynamics. In reputed company, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary reputed company $160,000-$224,000 USD Apply tot his job Apply To this Job