Sr. Director, Clinical Operations Job at Enveda

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Director Clinical Operations - Radiology

The Director, Radiology Clinical Operations, provides leadership and direction t...

Location

United States , Kansas City

Salary:

Not provided

The University of Kansas Health System

Expiration Date

Until further notice

Requirements

Master's Degree in related field of study from an accredited college or university
5 or more years of experience in Radiology or Imaging Services Leadership/Management
Fluent English - Must be able to read, write, understand, and speak English
Proficient in Quality Improvement Techniques and Lean methodologies
Commands advanced communication skills with various levels of professionals within multiple media/formats
Proficient with Microsoft Applications

Job Responsibility

Provides clinical direction and leadership to the Radiology Services
Directs clinical operations and integrates services within Radiology and with other departments
Directs and manages clinical oversight of all divisional depts
Creates effective work plans, which include identifying the correct resources, staffing, processes, and space needed by the work unit
Directs improvement work as process owner while guiding leaders and teams towards efficiency of work unit operations and use of resources
Sets the work unit's priorities in alignment with TUKHS priorities
Delegates authority and meets deadlines
Identifies needs of Radiology leaders and staff as well as customers to ensure priorities are aligned with the needs and priorities of Health system and other customers
Sets goals for each Radiology modality in collaboration with Sr. Director Radiology and Vice President Health professions
Ensures adequate resources are available to provide high quality care

Fulltime

Executive Director, Study Start-Up

In this vital role as Executive Director, Study Start-Up (SSU), you will lead SS...

Location

United States , Thousand Oaks

Salary:

281634.00 - 336501.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of clinical execution experience
Master’s degree and 10 years of clinical execution experience
Bachelor’s degree and 12 years of clinical execution experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
12+ years’ work experience in life sciences industry, particularly focusing on clinical trial work, including 10+ years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
Experience driving and leading organizations through cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs
Experience leading cross-functional / cross-geography / cross-trial teams, ensuring operational excellence and smooth decision-making
ability to escalate and resolve challenges in alignment with global study strategy priorities
Extensive knowledge of the clinical and pharmaceutical drug development process, from early to late-stage development with a deep understanding of relevant therapeutic areas to meet the highest scientific and regulatory standards

Job Responsibility

Shape the long-term vision and strategy of the SSU Hub, ensuring alignment with CPSO, GDO, and enterprise priorities
Integrate and harmonize strategies from the six sub-functions into a single global capability strategy, balancing standardization with local/regional adaptability
Act as the global escalation point for study start-up risks and issues, ensuring timely resolution and portfolio-level visibility
Embed within the industry - bringing outside ways of working and representing Amgen back into the industry
Build and develop a high-performing global SSU leadership team (Directors, Sr Managers) creating a culture of accountability, innovation and operational excellence
Lead, and mentor the global SSU Hub leadership team, ensuring robust succession planning, talent development, and organizational effectiveness
Drive consistent performance management, alignment, and calibration across sub-functions to ensure equitable resourcing and delivery
Embed a center of excellence mindset, encouraging knowledge-sharing and best practice adoption globally
Oversee start-up planning and execution across all new studies globally, ensuring timelines and quality standards are consistently achieved
Partner with Clinical Program Strategy and Operations TA Heads to ensure seamless integration of start-up into program execution

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Medical Science Liaison or Senior Medical Science Liaison

The Skeletal Conditions (SC) Medical Science Liaison (MSL) / Senior MSL is a reg...

Location

United States

Salary:

178200.00 - 267400.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS in life or health sciences
Advanced degree (MS, doctoral level) preferred
3 or more years of relevant experience in clinical and 1 or more year as an MSL preferred
Experience in rare genetic diseases, ACH and/or Skeletal Conditions therapy preferred
Experience in product launch, development, and execution preferred
Knowledge of regulations impacting Medical Affairs and field activities in the pharmaceutical industry
Excellent oral and written communication, organization, and people skills
Proven record as a team player
Project management understanding and experience
Ability to effectively work in a virtual environment and knowledge of virtual and collaborative systems

Job Responsibility

Execute SC medical MSL plan and tactics within assigned territory to meet scientific objectives and company-defined goals for products both marketed and in development
Development and periodic refinement of an approved MSL Territory Plan
Provide education relative to disease state and BioMarin products across product lifecycle to health care providers among specialties including Genetics, Pediatric Endocrinology, Pediatric Orthopedics, and other relevant specialties
Serve as a medical/scientific resource through answering unsolicited medical questions and addressing other related medical information queries
Engage in scientific exchange and provide feedback on emerging clinical/competitive trends
Identify, document, discuss and communicate insights to internal stakeholders
Maintain clinical and technical expertise in relevant therapeutic area
Partner with medical and research groups and compliantly collaborate with commercial team
Provide support to BioMarin clinical trials including but not limited to the following: site identification and evaluation
recruitment

What we offer

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

Fulltime

Global Study Director - Hematology/Oncology - Cell Therapy

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States; Canada , Montreal; Cary; Burlington; Blue Bell; Philadelphia; Pittsburgh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
Proven project management experience and training
At least 7 years of clinical trial experience
At least 3 years of experience in global study leadership and team leadership
Demonstrated clinical trial expertise in Hematology - Oncology
Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery
startup, maintenance and close out
Thorough understanding of the cross-functional clinical trial process eg. Data flow
Strong strategic and critical thinking abilities
Proven skillset and abilities in complex problem solving and decision-making

Job Responsibility

Lead and coordinate a cross-functional study team of experts in accordance with SDO/STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards
Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection
Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required
Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended)
Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan
For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations)
Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant
Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.), ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Medical Science Liaison or Senior Medical Science Liaison

The Skeletal Conditions (SC) Medical Science Liaison (MSL) / Senior MSL is a reg...

Location

United States

Salary:

178200.00 - 267400.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS in life or health sciences
Advanced degree (MS, doctoral level) preferred
3 or more years of relevant experience in clinical and 1 or more year as an MSL preferred
Experience in rare genetic diseases, ACH and/or Skeletal Conditions therapy preferred
Experience in product launch, development, and execution preferred
Knowledge of regulations impacting Medical Affairs and field activities in the pharmaceutical industry
Excellent oral and written communication, organization, and people skills
Proven record as a team player
Project management understanding and experience
Ability to effectively work in a virtual environment and knowledge of virtual and collaborative systems

Job Responsibility

Execute SC medical MSL plan and tactics within assigned territory
Development and periodic refinement of an approved MSL Territory Plan
Provide education relative to disease state and BioMarin products across product lifecycle to health care providers
Serve as a medical/scientific resource through answering unsolicited medical questions
Engage in scientific exchange and provide feedback on emerging clinical/competitive trends
Identify, document, discuss and communicate insights to internal stakeholders
Maintain clinical and technical expertise in relevant therapeutic area
Partner with medical and research groups and compliantly collaborate with commercial team
Provide support to BioMarin clinical trials including site identification and evaluation, recruitment, investigator meetings, external expert identification, and study management
Support clinical operations in identifying and interacting with potential investigators

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Sr. Practice Manager

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

28.50 - 37.06 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Associate's degree preferably with coursework in business administration or health care administration required
3 years administrative experience required
2 years management experience in healthcare or an equivalent combination of education and experience
Electronic Medical Record (EMR) skills with expert proficiency in all aspects, including Master Scheduling and Billing knowledge required
Advanced knowledge of medical practices, terminology, and reimbursement policies required
Intermediate Microsoft Outlook email skills (open new, to, cc, send) required
Intermediate electronic filing skills (name a file, save file, save as) required
Advanced typing skills required
Advanced proficiency with Microsoft Word and Excel required
Travel to office sites required

Job Responsibility

Oversees the operational components of the 7 procedure rooms in the Cardiac Catheterization and Electrophysiology Lab and the 17 exam rooms in the Paul Yu Heart Center
In conjunction with clinical leadership, promotes operational efficiency, high quality, outstanding patient experience, and strong financial performance
Directs staff using the ICARE framework, promoting a collaborative, diverse, and professional team
Responsible for performance management of all non-clinical staff in the practice
Operations Management: Supervises the operation and implement procedures for enhancing levels of service and quality and enforces medical office policies and procedures for the Cardiac Cath and EP Lab and the Paul Yu Heart Center
Develop guidelines for prioritizing and assigning work activities, evaluating effectiveness and modifying processes as necessary
Establishes and maintains efficient and responsive patient flow system
Ensure proper registration and insurance pre-verification management processes are followed including warm transfers to centralized functions
Manages insurance prior authorization for procedures scheduled in the lab
Manages the hospital transfers from area hospitals to the lab and back to transferring hospital

Fulltime

Manager clinical administration

Under the general direction, and direct supervision of the Sr. Administrator, se...

Location

United States of America , Rochester

Salary:

70197.00 - 105295.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 3 years relevant experience, including at least 2 years at a managerial level (personnel, fiscal and resource management)
Or equivalent related supervisory and administrative experience
5 years, minimally, of relevant experience in personnel, fiscal, and resource management relevant to the operations of complex clinical service systems
Demonstrated ability to be flexible and responsive in rapidly evolving health care environments
Excellent organizational and communication skills
Ability to lead in a positive, goal-directed manner

Job Responsibility

Under the general direction, and direct supervision of the Sr. Administrator, serves as a member of the leadership team in the Child and Adolescent Division
Works in collaboration with the Clinical leaders and Sr. Administrator to develop systems/processes that will assure that standards are met and efficient operations are achieved
Carries out strategic goals as set by the Division’s leadership for Child and Adolescent Acute Services including Brighter Days Urgent Care, CA Partial Hospital Service, Child CPEP and the Child Inpatient Unit
Supervises, coordinates, and monitors the work activity of OAR and PSR staff
Oversees scheduling for providers, develops goals and objectives, and is responsible for collaborating on annual operating budgets
Builds/edits and reviews report in eRecord and Tableau
Carries out responsibilities with considerable latitude for independent judgment
Fosters and enables a positive work environment by modeling the I CARE values
Ensure compliance with standards of care, HIPAA, OSHA and TJC policies
Oversee clinical compliance for quality assurance, documentation, and reporting

Fulltime

Sr. Director, Clinical Operations

Enveda

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 31, 2026

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