Clinical Trial Management Associate

The role:

The Clinical Trial Management Associate (CTMA) is a key member of the Clinical Operations team and will partner closely with the Clinical Trial Manager (CTM), Senior CTM, and Associate Director, Clinical Operations. The CTMA will support the execution of a global Phase 3 program, with a primary focus on study coordination, documentation, and operational support. Under the supervision of the Associate Director, Clinical Operations or the Senior CTM, the CTMA may manage sites within a region (e.g., EMEA or Americas) and/or vendors (e.g., IRT, eCOA, etc.)

 

Key responsibilities:

• Provide operational and administrative support for day-to-day clinical trial activities, including study start-up, maintenance, and close-out.
• Support site start-up activities, including tracking of site start-up components and assisting with site activation readiness.
• Accountable for study level tracking at Sponsor (e.g., monitoring visit tracking, sample tracking, patient tracking, site activation tracking, etc.)
• Act as a point of contact for CROs and study sites for routine communications and follow-ups, including escalations and engagement. Assist with coordination of investigator meetings and study-related communications.
• Track study timelines, deliverables, and key milestones; proactively follow up on outstanding items.
• Maintain internal Clinical Operations systems, trackers, and document repositories. Prepare and distribute study status updates and meeting minutes and ensure vendors do the same.
• Assist with vendor coordination and oversight, including vendor set-up, performance, and deliverable tracking. May assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations.
• Support review of study documents (e.g., informed consent forms, regulatory packages) and route for approval.
• Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and compliant manner; create, maintain, and close out TMFs; play a central role in setup, conduct, and close out of ancillary services; facilitate quality reviews and support trending activities.
• Facilitate and/or assist in review of CRO monitoring trip reports for completeness and consistency and, under supervision of other Operations personnel, may complete co-monitoring activities.
• Track protocol deviations and support trending activities.
• Support data review activities, including tracking queries and assisting with data listings review.
• Perform administrative duties in a timely manner as assigned.
• Adhere to Clinical Operations processes and SOPs.

 

Required experience & skills:

• BS or BA in a relevant scientific discipline or RN (2- or 3-year certificate)
• Minimum of 2 years of relevant clinical trial experience
• Clinical trial experience in the pharmaceutical or biotechnology industry 
• Excellent attention-to-detail, interpersonal and presentation skills are a critical asset
• Excellent organizational, problem-solving and time management skills
• Must be familiar with routine medical/scientific terminology
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
• Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency a plus)
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• High energy level, personal productivity, creativity and commitment
• Highly adaptable team-player; eager to learn
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
• This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable

 

Salary Range: $100,000 - $135,000

This role is eligible for a competitive total rewards package, including an annual bonus, equity, and a comprehensive benefits offering.