Clinical Supply Chain Manager - ETMF

About the role

The Clinical Supply Chain Manager (Contract) oversees electronic Trial Master Files (eTMF) for clinical supplies across multiple legacy clinical studies, ensuring inspection readiness, proper archival, and robust clinical supply planning. This role focuses on closed studies requiring eTMF archival, supports inspection readiness activities, and manages clinical supply chain planning from trial set-up through study closure within a regulated biopharmaceutical environment.

Responsibilities

• Manage electronic Trial Master Files (eTMF) for clinical supplies across multiple legacy clinical studies that have closed and require archival.
• Review clinical supply documentation to identify missing, incomplete, or mis-filed records and ensure they are properly addressed.
• Retrieve clinical supply documents from various internal repositories and systems to complete and reconcile eTMF content.
• Obtain required documentation from external vendors, including logistics service providers, distribution and storage depots, pass-through depots, and contract research organizations (CROs).
• Support document upload into the eTMF system and ensure all documents are inspection-ready and compliant with regulatory expectations.
• Organize documents in inspection readiness trackers at both the program and individual clinical study levels.
• Ensure all documents are logged in a consistent, traceable, and auditable manner across systems and trackers.
• Support inventory reconciliation activities to ensure clinical supplies are accurately accounted for in preparation for inspections.
• Oversee or execute tasks related to demand forecasting, supply planning, and inventory management of investigational product within clinical studies.
• Contribute to clinical study planning by supporting supply chain activities from trial set-up and launch through study closure, including clinical trial supply reconciliation and depot shutdown.
• Collaborate with cross-functional teams and external partners to maintain alignment on timelines, documentation requirements, and supply chain activities.
• Communicate status, issues, and risks related to eTMF completeness, inspection readiness, and clinical supply planning to relevant stakeholders.

Essential Skills

• At least 5 years of experience in clinical supply chain with a deep understanding of packaging, labeling, distribution, and storage of clinical trial supplies from set-up and launch through study closure, including supply reconciliation, accountability, and depot shutdown within a regulated biopharmaceutical environment.
• Strong knowledge and practical experience with GxP guidelines as they apply to clinical supply chain and documentation.
• Minimum 5 years of experience working with packaging and labeling vendors, including familiarity with their processes and documentation requirements.
• Minimum 5 years of experience collaborating with contract research organizations (CROs), contract manufacturing organizations (CMOs), and logistics service providers (LSPs).
• Hands-on experience managing electronic Trial Master Files (eTMF) for clinical supplies, including document retrieval, upload, and archival.
• Demonstrated ability to perform demand forecasting, supply planning, and inventory management for clinical studies.
• Proficiency with Smartsheet for tracking, planning, and managing clinical supply and documentation activities.
• Proficiency with Veeva Vault or similar eTMF/document management systems for organizing and maintaining inspection-ready documentation.
• Strong Excel skills for data analysis, tracking, and reporting related to clinical supplies and documentation.
• Excellent communication and interpersonal skills to interface effectively across multiple functions and with external partners.

Additional Skills & Qualifications

• Experience supporting inspection readiness activities for clinical programs and studies, including preparation for regulatory inspections.
• Strong attention to detail and commitment to maintaining consistent, traceable documentation practices.
• Ability to work effectively with multiple internal repositories and systems to locate and reconcile documentation.
• Experience collaborating with logistics service providers, distribution and storage depots, and pass-through depots to obtain required documentation.
• Strong organizational skills to manage multiple studies and documentation workflows simultaneously.
• Ability to work independently while coordinating with cross-functional teams in a regulated environment.

Work Environment

The role operates within a regulated biopharmaceutical environment focused on clinical trial supply chain and documentation. You will work extensively with electronic systems such as Veeva Vault for eTMF management, Smartsheet for tracking and planning activities, and Excel for data analysis and reporting. The position involves frequent interaction with internal cross-functional teams and external partners, including CROs, CMOs, and logistics service providers. Work is primarily office-based or remote-office in a structured setting, with responsibilities centered on documentation accuracy, inspection readiness, and coordination of clinical supply activities across multiple studies.

Job Type & Location

This is a Contract position based out of Rockville, MD.

Pay And Benefits

The pay range for this position is $30.00 - $37.00/hr.

Requirements

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.