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We are seeking a dedicated TMF Project Manager who will provide day-to-day record management support across various teams, ensuring smooth operations in clinical trial management. This role requires establishing standards, processes, and reports, as well as providing oversight to CROs and supporting internal and external audits.

Responsibilities

+ Provide day-to-day record management support to various departments including Clinical Operations, Clinical Development, and Data Management.

+ Offer TMF oversight to CROs and act as the initial point of contact for TMF process-related inquiries.

+ Attend routine clinical trial meetings as the TMF Lead, collaborating with CROs, service providers, and internal teams.

+ Establish and maintain standards, requirements, and processes for clinical trial records, including those outsourced to CROs.

+ Develop and implement TMF standard operating procedures and common work practices across different clinical programs.

+ Create and manage TMF Plan and TMF Oversight Plan templates and standard content for all phases of clinical trials.

+ Lead system setup for Phase 1 trials and support Clinical Operations in TMF reviews.

+ Oversee the creation and implementation of TMF Plans and maintenance activities for outsourced Phase 2 and 3 trials.

+ Facilitate periodic oversight reviews of CRO TMFs and manage resolution of queries.

+ Identify and resolve TMF-related issues and manage escalation as needed.

+ Lead the migration and archival process of CRO TMFs into the in-house eTMF system.

+ Manage and oversee the service provider for the in-house eTMF system.

+ Ensure training of team members on TMF-related SOPs and processes.

+ Support Clinical Operations and Quality Assurance during audits and inspections.

Essential Skills

+ Bachelor's Degree

+ 6+ years of experience in Biotech/Pharmaceutical industry

+ 3+ years of TMF Management experience in a GCP regulated environment

+ Experience in CRO TMF Oversight

+ Extensive knowledge of ALCOA+ standards

+ Experience with TMF reference Model

+ Experience within Phase I-III of clinical trials

+ Experience with TMF Systems such as Phlexglobal, Wingspan, and Clintrak

Additional Skills & Qualifications

+ Experienced and comfortable working in a fast-paced environment

+ Ability to work cross-functionally and with external vendors, fostering positive relationships

+ Excellent verbal and written communication skills

+ Outstanding organizational skills, attention to detail, and follow-through

+ Strong interpersonal skills, capable of working independently and collaboratively

+ Ability to handle multiple tasks simultaneously and adapt to changes in responsibilities

Work Environment

This is a fully remote opportunity, requiring work in EST or CST time zones. The role demands collaboration with European counterparts, offering flexibility and the chance to be part of a dynamic and growing team.

Pay and Benefits

The pay range for this position is $65.00 - $68.00/hr.

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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jul 30, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.