CTMS Operations Manager

Posted 5 Hours Ago
Be an Early Applicant
Hiring Remotely in USA
Remote
90K-120K Annually
Senior level
Other
The Role
The CTMS Operations Manager oversees the CTMS platform governance, manages CTMS operations team, ensures audit readiness, maintains operational reporting, and supports configurations and integrations with various stakeholders while leading people and process improvements.
Summary Generated by Built In

About Care Access

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

To learn more about Care Access, visit www.CareAccess.com.

How This Role Makes a Difference

The CTMS Operations Manager owns CTMS platform governance, technical support for other Care Access users, operational reporting, and the CTMS operations team that executes these requirements. This role is both people leader and technical owner: final gatekeeper for CTMS site and study builds, owner of platform/configuration standards and release/change control, primary liaison to our CTMS vendor(s), Study Start-Up (SSU), Source, Study Ops, Operational Excellence, Site Network, and QA, and lead for CTMS-sourced operational reporting. The role ensures build quality, SOP/GxP compliance, audit readiness, and continuous improvement of CTMS processes and KPIs. 

How You'll Make An Impact
  • Platform governance & final acceptance. Serve as final reviewer of CTMS build; approve builds for release and escalate/resolve gating defects. Document and enforce naming conventions and other configuration standards.   
  • Coordinate with SSU, Source, Study Ops, Operational Excellence, Site Network, QA, Data/Analytics, and vendors for integrations, handoffs, and incident resolution. 
  • Own CTMS-sourced dashboards and reports; define KPIs and lead process improvements. 
  • Hire, coach, allocate workload, conduct performance management and career development for CTMS Operations Analysts. Define role responsibilities and training plans; maintain training completion KPIs. 
  • Own CTMS SOP alignment, change control calendar, validation/testing for upgrades/releases, and audit readiness.

Other Responsibilities 

  • Lead change-control reviews for CTMS configuration changes and release planning.
  • Maintain a CTMS runbook, build checklists, and training materials.  
  • Lead platform admin escalation and vendor relationships for system fixes or product changes. 
  • Represent CTMS operations in cross-functional governance meetings and study readiness reviews. 
The Expertise Required

Knowledge, Skills, and Abilities: 

  • Deep working knowledge of CTMS configuration, study builds, and operational governance. (Experience with Conductor, Florence, Veeva, or comparable CTMS preferred) 
  • Proven people management skills: hiring, coaching, performance management and capacity planning. 
  • Strong stakeholder management and ability to operate cross-functionally with SSU, Study Ops, QA and vendor teams. 
  • Technical fluency: ability to read/run platform queries, understand integrations, and drive release testing. 
  • Strong written/verbal communication, documentation skills, and attention to detail. 
  • Familiarity with ICH-GCP, SOPs, and audit processes. 
Certifications/Licenses, Education, and Experience
  • Bachelor’s degree preferred (or equivalent experience). 
  • 5+ years of CTMS/platform or clinical systems experience, with 2+ years in a team lead/managerial role or equivalent leadership experience. 
  • Preferred certifications: CTMS platform admin certs, GCP/clinical research certifications, or relevant technical certifications. 
How We Work Together
  • Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
  • Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
  • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

The expected salary range for this role is $90,000 - $120,000 USD per year for full time team members.

Benefits & Perks (US Full Time Employees)
  • Paid Time Off (PTO) and Company Paid Holidays
  • 100% Employer paid medical, dental, and vision insurance plan options
  • Health Savings Account and Flexible Spending Accounts
  • Bi-weekly HSA employer contribution
  • Company paid Short-Term Disability and Long-Term Disability
  • 401(k) Retirement Plan, with Company Match 

Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. 

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for a role with Care Access, please reach out to: [email protected]

Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: 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.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. 

Skills Required

  • Deep working knowledge of CTMS configuration and operational governance
  • Proven people management skills
  • Strong stakeholder management experience
  • Technical fluency with platform queries and integrations
  • Familiarity with ICH-GCP and audit processes
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The Company
HQ: Boston, MA
818 Employees

What We Do

Care Access is a leading decentralized research organization (DRO) that breaks down traditional barriers in clinical research for patients, sponsors, and physicians. Its innovative model brings decentralized trials, Sites On Demand™, Virtual PIs, and Mobile Sites to previously-unreachable patient populations to expand the impact of clinical research. Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster. To find out how Care Access is transforming the future of clinical trials, visit www.careaccess.com or email [email protected].

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