Join Us as an Associate Director, Registry Operations Management We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech, spanning 2,700 clinical trials across 100+ countries in the last five years.
As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What will you do in this role?
The Associate Director, Registry Operations Management provides senior operational leadership for a portfolio of CorEvitas registries and real-world evidence programs. The role translates program commitments into coordinated delivery plans, oversees operational performance and risk, and aligns cross-functional teams, sites, vendors, and client stakeholders. The Associate Director leads complex programs and develops team capability while improving the consistency and scalability of registry operations.
Provide operational leadership for assigned registries across start-up, site activation, enrollment, ongoing data collection, maintenance, and closeout, as applicable.
Convert protocols, contracts, client commitments, and program objectives into integrated plans, milestones, staffing assumptions, and risk controls.
Monitor portfolio health and intervene on material risks, dependencies, delays, quality issues, and changes in scope; escalate decisions at the appropriate level.
Ensure program records, governance, and operational decisions are documented in accordance with company procedures and applicable requirements.
Cross-functional leadership
Coordinate delivery with Clinical Operations, Data Management, Biostatistics, Epidemiology, Medical and Scientific Affairs, Quality, Technology, Finance, Contracts, and client-facing teams.
Clarify accountability, handoffs, decision rights, and dependencies across functions; lead operational reviews and governance discussions for assigned programs.
Communicate concise, evidence-based status updates, options, and recommendations to senior internal stakeholders and clients.
Site, enrollment, and client performance Oversee site activation, enrollment, retention, data collection, and participation trends; guide targeted plans for underperforming sites.
Use key operational indicators to identify emerging issues and improve site engagement and registry performance.
Represent Registry Operations in client meetings and planning forums; assess the operational, timeline, resource, and financial impact of proposed changes with partner functions.
Quality and operational excellence Promote quality, compliance, inspection readiness, patient-centered research, and timely issue escalation.
Partner with Quality and functional leaders on audits, inspections, investigations, corrective and preventive actions, and sustained remediation.
Lead process improvements that strengthen consistency, cycle time, stakeholder experience, and operational scalability; develop practical standards, tools, and metrics.
People and business leadership Coach and develop Registry Operations colleagues; set expectations, manage workloads, and support talent development and succession planning.
Contribute operational expertise to feasibility assessments, proposals, budgets, resource estimates, and portfolio capacity planning.
Contribute to annual planning and strategic initiatives involving registry growth, technology adoption, and the operating model.
Education Requirements:
Bachelor’s degree in life sciences, healthcare, public health, clinical research, business, or a related field is required ; advanced degree MPH, MS, MBA, or equivalent preferred.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Experience Requirements:
Typically, 8 or more years of experience in clinical research operations, registry operations, observational research, real-world evidence, clinical operations, or a related area is required .
Demonstrated success leading complex cross-functional programs and working with sites or site networks in a regulated research environment is required.
Experience with longitudinal registries, observational studies, or post-marketing research and with biopharmaceutical or biotechnology clients is preferred.
Experience with people-management or significant team leadership equivalent to 5 years is required.
Must be able to work East Coast hours!
Knowledge, Skills, Abilities:
Strong program leadership, planning, risk management, issue resolution, and performance management skills.
Ability to interpret operational data and turn findings into clear actions and recommendations.
Sound judgment in balancing scientific, operational, client, financial, and organizational needs.
Effective written and verbal communication, stakeholder management, negotiation, and influencing skills.
Ability to lead through ambiguity, solve root causes, and implement improvements that last.
Location: Remote in the United States . Relocation assistance is NOT provided.
Must be legally authorized to work in the US without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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