Associate Director, Registry Operations Management

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an Associate Director Registry Operations Management

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech spanning 2700 clinical trials across 100 countries in the last five years.

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:

Bachelors 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 withoutsponsorship.

*Must be able to pass a comprehensive background check whichincludes 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 100000 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.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Required Experience:

Director