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Full Time Biomarker Operations Jobs (NOW HIRING)

The company reserves the right to modify onsite requirements, including transitioning to full-time ... biomarker-driven studies). * Provide expertise and leadership to ensure TMF inspection readiness ...

... | Full-Time pay: Up to 34.45/hr DOE Position Summary The Sample & Lab Coordinator (SLC) is ... Support biospecimen workflows for Biomarker, Companion Diagnostics (CDx), pharmacokinetic (PK ...

$17.75 - $23.50/hr

By collating a large set of biomarkers on an integrated platform, Ultrahuman is able to create a ... Employment Type: FULL_TIME

... biomarkers in our arsenal. We are snowballing and are backed by investors such as Alpha Wave ... Employment Type: FULL_TIME

This position is a full time laboratory-based position. Essential Functions/Responsibilities ... Develop proper operational, data documentation, and troubleshooting procedures. * Such other ...

This position is a full time laboratory-based position. Essential Functions/Responsibilities ... Develop proper operational, data documentation, and troubleshooting procedures. * Such other ...

Warehouse Associate I Billerica, MA Quanterix is a global leader in ultra-sensitive biomarker ... This is a full-time, on-site position, Monday through Friday. WHAT YOU'LL DO: * Processes orders ...

Warehouse Associate I

Billerica, MA ยท On-site

$24.04 - $28.85/hr

This is a full-time, on-site position, Monday through Friday. WHAT YOU'LL DO: * Processes orders ... From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling ...

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Full Time Biomarker Operations information

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How much do full time biomarker operations jobs pay per hour?

As of Jun 25, 2026, the average hourly pay for full time biomarker operations in the United States is $26.24, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $30.29 per hour, depending on experience, location, and employer.

What are Full Time Biomarker Operations?

Full Time Biomarker Operations professionals are responsible for managing and coordinating all aspects of biomarker-related activities in clinical research or pharmaceutical development. They oversee the collection, processing, analysis, and storage of biological samples to identify and validate biomarkers. Their work ensures that biomarker data is accurate, regulatory compliant, and supports the goals of drug development or clinical studies. These roles often involve cross-functional collaboration with clinical teams, laboratories, and data management groups.

What are the key skills and qualifications needed to thrive as a Full Time Biomarker Operations professional, and why are they important?

To thrive in Full Time Biomarker Operations, you need a strong background in life sciences, clinical research, and biomarker assay development, typically with a relevant degree such as biology or biochemistry. Familiarity with laboratory information management systems (LIMS), Good Clinical Practice (GCP) guidelines, and assay validation tools is essential. Excellent organizational skills, attention to detail, and effective cross-functional communication set candidates apart in this role. These skills are critical for ensuring the accurate collection, analysis, and management of biomarker data that drive research and clinical trial success.

What are some typical challenges faced in a Full Time Biomarker Operations role, and how can they be effectively managed?

Professionals in Full Time Biomarker Operations often encounter challenges such as coordinating complex multi-site clinical studies, ensuring compliance with evolving regulatory requirements, and managing large volumes of biological sample data. Effective management involves strong project management skills, clear communication with cross-functional teams, and staying updated on industry standards. Leveraging robust tracking systems and fostering collaboration between clinical, laboratory, and data management teams can help mitigate these challenges and ensure study timelines are met.
More about Full Time Biomarker Operations jobs
What cities are hiring for Full Time Biomarker Operations jobs? Cities with the most Full Time Biomarker Operations job openings:
What are the most commonly searched types of Biomarker Operations jobs? The most popular types of Biomarker Operations jobs are:
Infographic showing various Full Time Biomarker Operations job openings in the United States as of June 2026, with employment types broken down into 91% Full Time, and 9% Contract. Highlights an 83% Physical, 3% Hybrid, and 14% Remote job distribution, with an average salary of $54,588 per year, or $26.2 per hour.
Associate Director, TMF Operations

Associate Director, TMF Operations

SystImmune, Inc

Princeton, NJ โ€ข On-site

$140K - $180K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 25 days ago


Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
We are an emerging biotech company focused on developing transformative oncology therapies. As we advance our clinical pipeline, we are seeking an Associate Director, TMF Operations to lead Trial Master File (TMF) operations across our oncology programs. This role provides strategic leadership and oversight of electronic Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality. The ideal candidate will possess TMF system and process expertise, exceptional vendor oversight, and a strong foundation in inspection readiness and support.
Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs, and analytics. The role involves collaborating with senior leaders and key stakeholders to establish, manage, and generate reports and analytics that support performance measurement, delivery optimization, and continuous improvement.
This position currently requires a minimum of three days onsite per week in Princeton, NJ. The company reserves the right to modify onsite requirements, including transitioning to full-time onsite, based on business needs.
Responsibilities
  • Provide leadership and strategic direction to ensure TMF processes and related documentation are of the highest quality for in-house and outsourced studies.
  • Develop and oversee global TMF-related standards, standard operating procedures (SOPs) and TMF Plans that are in line with relevant regulations and industry best practices.
  • Ensure TMF structure aligns with the DIA TMF Reference Model and supports complex oncology protocols (e.g., adaptive designs, biomarker-driven studies).
  • Provide expertise and leadership to ensure TMF inspection readiness and facilitate seamless support of audits and regulatory inspections.
  • Develop, generate, analyse, and report on standard TMF metrics/KPIs to demonstrate TMF health.
  • Facilitate and perform periodic TMF health checks and QC reviews to ensure completeness, accuracy, and timeliness.
  • Provide operational leadership to TMF vendor budget negotiations and management of TMF operations spend.
  • Create and lead training across all relevant business units/functional areas on business processes around clinical document management and eTMF system(s).
  • Oversee CRO/vendor partners to ensure TMF tasks are completed according to contractual requirements.
  • Serve as area representative for the implementation of any systems or processes that would interface/integrate with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC).
  • Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management
  • Oversee and support the registration, maintenance, and compliance of clinical trial postings on appropriate clinical trial registries (e.g., ClinicalTrials.gov) in coordination with the cross-functional team.
  • Support the development and coordination of procedures and programs to enhance team understanding and compliance with clinical trial disclosure regulations and requirements.

Qualifications
  • Bachelor's degree or a combination of relevant education and applicable experience may be considered.
  • 10+ years of experience in clinical research within the pharmaceutical/biotech industry and a minimum of 5 years in TMF process management and oversight.
  • Demonstrated proficiency with eTMF systems and TMF metrics/reporting,
  • Experience with Veeva eTMF platform, strongly preferred.
  • Strong understanding of ICH-GCP, DIA TMF Reference Model, and global regulatory requirements.
  • Comfortable working in a fast-paced, evolving environment with limited structure.
  • Clear and timely communication skills.
  • Strong organizational/prioritization skills for the management of workload and attention to detail.

Compensation and Benefits:
The expected base salary range for this position is $140,000 - $180,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's level qualifications, experience, and skills.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.