Manager, Trial Master File (TMF)

Clinical Waltham, Massachusetts


Description

Position Summary:

The Trial Master File Manager will assist in all aspects of Trial Master File (TMF) Management at Apellis.  This person will work with cross-functional Functional Areas in the development and implementation of policies and procedures relative to and for the TMF as well as provide training, support and subject matter expertise to key stakeholders.

Responsibilities:

  • Provide day to day document management support to Clinical Operations, Clinical Research, Data Management, Medical Writing, Statistics and Statistical Programming, Clinical Supply Chain, Regulatory and Safety and be an initial point of contact for Trial Master File (TMF) process related questions
  • Ensure standard service level agreements are maintained
  • Ensure adherence to Standard Operating Procedures, Good Clinical Practice, Good Documentation Practices, International Council for Harmonization E6(R2), and ALCOA+ standards
  • Author, contribute to, maintain and implement TMF Management Controlled Documents and associated resources (e.g. training materials, knowledge databases)
  • Administer on-site training, across Clinical Development, on the policies and procedures relative to and for document quality and process
  • Perform and manage ad hoc TMF Quality Assessments
  • Lead appropriate Clinical Development document-related Regulatory Inspection Readiness Activity
  • Act as a system of record (i.e. eTMF) expert and an initial point of contact for system related questions
  • Play a pivotal role in the generation, interpretation, cascade and escalation of metrics for the TMF
  • Work with Contract Research Organization (CRO) partners and Third-Party Clinical Vendors on the continued development of TMF and Record Management practices and expectations

Qualifications:

  • Attention to detail
  • Good written and verbal communication skills
  • Excellent interpersonal and organizational skills
  • Ability to work independently, self-supported
  • Ability to manage multiple projects and to effectively prioritize tasks
  • Ability to manage external vendors

Experiences:

  • Strong interpersonal skills and ability to manage all levels within a cross-functional organization through inspiration and influence
  • Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude
  • Extensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelines
  • Strong TMF Reference Model and eTMF system (Veeva Vault eTMF preferred) experience
  • Knowledgeable in domestic and global regulatory requirements and guidance
  • Working knowledge of Regulatory Agency Audits and NDA/MAA Submission triggered Inspections preferred
  • Bachelor’s Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities for this position
  • Minimum 5 years pharmaceutical / biotechnology industry experience
  • Minimum 3 years records management experience in a GCP-regulated environment and with Essential TMF Documents

Other:

Applicants must be authorized to work in the U.S.

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 http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

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 pneumocononiosis or any other characteristic protected under applicable federal, state or local law.