• Sr. Clinical Trial Manager

    Actalent (Menlo Park, CA)


    Sr. CTM role

     

    2 days on site in Menlo Park, CA

    3 days remote (hybrid role)

    + Ability to run a full trial (start up, maintence, close out) independently

    + Experience with diagnostics is a plus but not required

    + Bio/pharma experience is recommended as well as the whole team comes from pharma

    + Ability to work cross functionally with teams and get along with a lot of different personalities

    + Ability to share knowleddge but also find a solution based on what is best for everyone

    Description

    • Serves as the Clinical Operations Study Lead for assigned studies, providing strategic and operational leadership to ensure successful planning, execution, and delivery of clinical studies.

    • Supports and guides Clinical Trial Managers and Clinical Project Assistants ensuring alignment of study activities, promoting best practices, and driving a unified approach to achieve study objectives.

    • Acts as the primary point of contact for internal cross functional teams

    • Leads site management and performance oversight, including ensuring proper training, fostering strong site relationships, and monitoring compliance with study protocols, plans, SOPs, GCP/ICH, and all applicable regulatory requirements.

    • Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out

    • Develops study related plans and documents, including informed consent forms, ensuring alignment with study objectives, regulatory requirements, and overall study strategy.

    • Collaborates on site identification and selection.

    • Participates in EDC set-up by contributing to case report form design, user acceptance testing, development of completion guidelines, and other related activities, supporting study requirements and data quality.

    • Oversees clinical data entry progress ensuring timely resolution of incomplete data and outstanding queries.

    • Contributes to the development and management of site budgets and ensures timely and accurate invoice payments in accordance with site payment terms

    • Partners with cross functional stakeholders such as Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Science, and Lab Operations to define study strategy, align operational plans, and proactively identify and mitigate risks to ensure successful execution.

    • Provides oversight of regional study monitors and/or contract research organizations (CRO) to ensure quality, compliance, and timely study execution while proactively addressing risk and performance issues.

    • Facilitate external communication with site staff and pharmaceutical partners (as applicable).

    • Ensures electronic Trial Master File (eTMF) is current and maintained

     

    Skills

     

    Clinical trial, Vendor management, oncology, Project management, Clinical research, Clinical trial management, IVD

     

    Top Skills Details

     

    Clinical trial,Vendor management,oncology

    Additional Skills & Qualifications

    • Bachelor’s degree or equivalent in the life sciences or related field required.

    • Additional coursework in clinical trial planning and execution is strongly desired

    • Ideal candidate will have at least 5 years of relevant experience in managing clinical trials, with at least 2 years experience in a Clinical Operations study lead role, at a sponsor company (pharma, biotech, or medical device) with a strong track record of successful trial initiation and execution

    • Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable

    • Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements

    • Working experience with an electronic data capture system, CTMS system, and eTMF system.

    • Strong interpersonal communication (written and verbal), organizational and prioritization skills

    • Able to work effectively under a fast-paced and changing environment

    • Strong work ethic and demonstrated ability to deliver assignments on time

    • Proficient with office automation tools, such as Microsoft Office and the Google suite of apps

    Experience Level

    Expert Level

     

    Job Type & Location

     

    This is a Permanent position based out of Menlo Park, CA.

    Pay and Benefits

    The pay range for this position is $140000.00 - $164000.00/yr.

     

    Medical, Dental, VIsion, 401k

     

    Workplace Type

     

    This is a fully onsite position in Menlo Park,CA.

     

    Application Deadline

     

    This position is anticipated to close on Dec 26, 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.