Executive Director, Data & Technology Clinical Operations Job at Parexel

Senior Medical Director, Clinical Development

Cabaletta is seeking an experienced, highly motivated hands-on physician leader ...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

D., M.D./Ph.D. degree or equivalent required
Board Certification, Board Eligibility, or clinical experience in the field of Rheumatology and/or Immunology highly desirable
7+ years of experience in clinical research, including the design and execution of complex clinical trials, with a pharmaceutical or biotech company
Experience with or exposure to the development of adoptive cell therapies or biologic therapies is desirable
Experience with Health Authority interactions and submission of clinical regulatory documents is desirable
Strong written and verbal communication skills
ability to easily engage with investigators and key external experts
and ability to effectively present at conferences, advisory meetings, and other public for a
Engaged, hands-on, independent, and goal-oriented mentality
willingness to work in highly dynamic work environment

Job Responsibility

Provide medical leadership for various programs from first-in-human studies through registrational studies
Formulate study designs, lead protocol development, partner with internal cross-functional teams in study start-up activities, and collaborate with clinical investigators, key external experts, and Health Authorities
Participate in direct, hands-on involvement in all aspects of study conduct clinical activities, working with clinical operations, including data review, analysis, and reporting that conform to the ethical, safety, and quality standards of Cabaletta, GCP, and Health Authorities
Become an expert and remain current in the relevant therapeutic areas and in the field of cell and gene therapy through review of the scientific literature, interactions with key external experts, and attendance at relevant scientific meetings
Actively contribute during Health Authority interactions
Review available preclinical data that could inform the design of future clinical trials
Present at site evaluation and site initiation visits as applicable
In partnership with relevant cross-functional team members, actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
Collaborating with cross-functional groups, formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data

What we offer

health and retirement, PTO, and stock option plans

Executive Director, Data & Technology Site & Study Startup Support

The Executive Director, D&T Site & Study Startup Support serves as the senior te...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

15+ years of experience in clinical operations technology, Site & Study Startup processes, feasibility, regulatory workflows, or related domains
Experience implementing enterprise clinical systems and managing cross‑functional integrations
Proven ability leading global, matrixed technology or operational teams
Bachelor’s degree in Life Sciences, Engineering, Business, or related discipline required
Master’s degree or equivalent experience preferred
Deep knowledge of site and study startup processes (feasibility, submissions, activation, regulatory workflows)
Strong understanding of clinical operational systems and data flows
Expertise delivering technology solutions in regulated clinical research environments
Executive‑level communication, influence, and cross‑functional leadership
Ability to translate operational challenges into system and data improvements

Job Responsibility

Serve as the primary D&T executive partner for the global Site & Study Startup function, ensuring alignment to operational processes and startup lifecycle needs
Drive system enhancements that improve startup predictability, data capture, cycle times, and risk identification
Use innovative technology to improve effectiveness and efficiency of the business
Partner with business leaders to ensure systems availability and support for feasibility modeling, country and site selection, document collection and workflows, ICF customization, EC/RA/MoH submissions, SIV scheduling and activation readiness
Provide technology, analytical models, and data tools for feasibility assessments
Ensure real‑time access to feasibility insights, performance history, and site data across data platforms
Oversee integrations between Site & Study Startup systems and broader D&T ecosystem systems
Coordinate with regulatory and compliance technology partners to ensure consistent data flows
Ensure end‑to‑end system readiness and integration for regulatory document management, site regulatory package preparation, greenlight/activation processes, system setup and training workflows
Build and scale reporting capabilities that measure startup progress, activation risks, feasibility metrics, and regulatory timelines

What we offer

Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Opportunity to work on innovative projects at the forefront of the industry
Collaborative and inclusive work environment that values your expertise
Professional advancement and development opportunities

Data Engineering & Analytics Lead

Premium Health is seeking a highly skilled, hands-on Data Engineering & Analytic...

Location

United States , Brooklyn

Salary:

Not provided

Premium Health

Expiration Date

Until further notice

Requirements

Bachelor's degree in Computer Science, Engineering, or a related field. Master's degree preferred
Proven track record and progressively responsible experience in data engineering, data architecture, or related technical roles
healthcare experience preferred
Strong knowledge of data engineering principles, data integration, ETL processes, and semantic mapping techniques and best practices
Experience implementing data quality management processes, data governance frameworks, cataloging, and master data management concepts
Familiarity with healthcare data standards (e.g., HL7, FHIR, etc), health information management principles, and regulatory requirements (e.g., HIPAA)
Understanding of healthcare data, including clinical, operational, and financial data models, preferred
Advanced proficiency in SQL, data modeling, database design, optimization, and performance tuning
Experience designing and integrating data from disparate systems into harmonized data models or semantic layers
Hands-on experience with modern cloud-based data platforms (e.g Azure, AWS, GCP)

Job Responsibility

Collaborate with the CDIO and Director of Technology to define a clear data vision aligned with the organization's goals and execute the enterprise data roadmap
Serve as a thought leader for data engineering and analytics, guiding the evolution of our data ecosystem and championing data-driven decision-making across the organization
Build and mentor a small data team, providing technical direction and performance feedback, fostering best practices and continuous learning, while remaining a hands-on implementor
Define and implement best practices, standards, and processes for data engineering, analytics, and data management across the organization
Design, implement, and maintain a scalable, reliable, and high-performing modern data infrastructure, aligned with the organizational needs and industry best practices
Architect and maintain data lake/lakehouse, warehouse, and related platform components to support analytics, reporting, and operational use cases
Establish and enforce data architecture standards, governance models, naming conventions ,and documentation
Develop, optimize, and maintain scalable ETL/ELT pipelines and data workflows to collect, transform, normalize, and integrate data from diverse systems
Implement robust data quality processes, validation, monitoring, and error-handling frameworks
Ensure data is accurate, timely, secure, and ready for self-service analytics and downstream applications

What we offer

Paid Time Off, Medical, Dental and Vision plans, Retirement plans
Public Service Loan Forgiveness (PSLF)

Fulltime

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
Expertise in project management practices
Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
Exceptional organizational and team leadership skills

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Clinical Strategy Development: Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Conduct Clinical Research: Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
Expertise in project management practices
Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
Exceptional organizational and team leadership skills

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project
Facilitate preparation of protocols including study design, case report forms, study procedures

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum: BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Able to monitor performance of team in maintaining system updates to allow for senior management reports
Applies current applications/systems to compile information for presentation or distribution
Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Clinical Strategy Development: Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Conduct Clinical Research: Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Chief Operating Officer and Chief Nursing Officer

We have an exciting opportunity to join our leadership team at Pascack Valley Me...

Location

United States , Westwood

Salary:

179003.00 - 226423.00 USD / Year

Ardent Health

Expiration Date

Until further notice

Requirements

Bachelor's degree nursing required
Master's degree nursing or MHA or MBA related field required
5+ years of experience in hospital administration & 5+ in clinical nurse leadership and experience as a Chief Nursing Officer required
Current licensure as a registered professional nurse (RN) in the state in which he or she practices, in accordance with law and regulation required
Excellent leadership and interpersonal skills to effectively communicate ideas, problems, instructions (written and oral) with corporate management staff, facility management staff and employees.
Ability to analyze situations, evaluate data, recommend, and implement courses of action that would improve the functioning of the company.
Ability to interpret, adapt, and apply guidelines, policies and procedures.
Ability to use sound judgment in decision making and react calmly and effectively in an emergency situation.
Knowledge of strategic planning and short and long-range goal implementation.

Job Responsibility

Provides administrative direction, evaluation, and coordination of the functions and activities for the operation of assigned clinical and non-clinical departments.
Collaborates routinely with the CEO concerning policy recommendations and suggested courses of action pertinent to the efficient operation of assigned departments.
Manages the implementation for major strategic, clinical and/or operational initiatives.
Mentors and develops leaders, fostering achievement of goals and objectives, high performing leadership practices, collaboration, and innovation.
Guides department leaders in establishing measures of performance, increased productivity, quality improvement, and cost management.
Enhances quality outcomes by partnering with leadership for shared clinical decision making, but maintain overall responsibility for all of patient care. CNO has overall responsibility for patient care.
Collaborates with directors in hiring, orientation, evaluation, discipline, and education of clinical staff.
Assures the flow of information and decision-making is bi-directional and horizontal among all professional nurses, the CNO, and the leadership team.
Establish and enhance a culture of evidence-based practice in clinical and management initiatives.
Approves nursing policies, nursing standards of patient care, treatment, and services.

Fulltime

Director of Implementation (Enterprise)

The Director of Implementation (Enterprise) is responsible for leading the succe...

Location

United States , Bethesda

Salary:

Not provided

Aledade, Inc.

Expiration Date

Until further notice

Requirements

10+ years of experience of relevant experience in healthcare technology
Experience leading enterprise-level implementations, preferably in an Epic environment
Bachelors or Masters (preferred) degree in technical field or other relevant field
Demonstrate knowledge across all EHR implementation, optimization, and data integration strategies and standards
Experience configuring and managing enterprise SaaS applications, preferably population health tools

Job Responsibility

Develop, oversee, and optimize a portfolio of enterprise-level onboarding projects from initiation through completion.
Navigate complex, non-standard implementation scenarios with agility, ensuring milestones are achieved consistently and at scale.
Direct cross functional teams to guarantee timely delivery of product and technical commitments while maintaining high client satisfaction.
Serve as the primary point of contact on technical delivery for enterprise clients, building strong partnerships and trust with executive, clinical, and technical stakeholders.
Manage and mentor a team of implementation specialists and EHR subject matter experts.
Develop and maintain best-practice workflows for top-tier EHR systems, with an emphasis on Epic, to support value-based care and ACO initiatives.
Ensure adherence to all applicable compliance requirements, including Certified EHR technology standards, Promoting Interoperability attestations, and accurate clinical quality measure reporting.
Monitor and drive performance against key implementation metrics to meet organizational goals.
Identify process improvements to enhance efficiency, scalability, and quality across implementation operations.

What we offer

Flexible work schedules and the ability to work remotely are available for many roles
Health, dental and vision insurance paid up to 80% for employees, dependents and domestic partners
Robust time-off plan (21 days of PTO in your first year)
Two paid volunteer days and 11 paid holidays
12 weeks paid parental leave for all new parents
Six weeks paid sabbatical after six years of service
Educational Assistant Program and Clinical Employee Reimbursement Program
401(k) with up to 4% match
Stock options

Fulltime

Executive Director, Data & Technology Clinical Operations

Parexel

Location:
United States

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 04, 2026

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