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

New

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

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

Region Director Clinical Education

This role provides leadership and accountability in the strategic and daily oper...

Location

United States , Centennial

Salary:

61.31 - 95.23 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Bachelor Degree Nursing Required Graduated from an accredited school of BSN (required only if master's degree is not in Nursing)
Master Degree Required MSN or other master's degree
4 years of progressive nursing leadership experience required
1-3 years leading education programs or departments required
Registered Nurse State of Employment Required RN license to practice in state of employment as applicable
Nursing Specialty Certification: Required sit within 6 months:achieve within 1 year of hire or transfer to the role

Job Responsibility

Provides leadership and accountability in the strategic and daily operations of the Regional education department
Develops and maintains excellent leadership and associate relations
Accountable for leading the enterprise Education Department associates to assess, develop, maintain, and evaluate the orientation, in-service, continuing education, competency assessment and other programs for clinical employees, volunteers, contract staff, students and others as needed
Organizes, leads, and partners with leadership across the system towards professional development, integration of best practices, oversight of informal and formal education programs for clinicians, as well as evaluation of effectiveness and strategic planning to address organizational priorities and patient outcomes
Supports the enterprise's journey to excellence aligned with the evidence based American Nurses' Credentialing Center (ANCC) Magnet or Pathway programs
Works in collaboration with the Enterprise Sr. VP and CNO and Enterprise VP for Nursing Excellence and Professional Development to establish a vision for professional development and education services that supports activities, structures and processes for optimal work environment and teamwork for professional nurses and inter-professional members, resulting in outstanding patient care outcomes

What we offer

Medical
prescription drug
dental
vision plans
life insurance
paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
tuition reimbursement
retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

New

Controller

We are looking for you as a Controller (m/f/d) in the area of revenue controllin...

Location

Germany , Hamburg

Salary:

Not provided

Deutsche Bahn

Expiration Date

Until further notice

Requirements

successfully completed university degree in business administration, ideally with a focus on finance and accounting, or a comparable qualification
several years of professional experience in controlling
strong business acumen
independent way of working
high affinity for numbers, deadlines and quality
confident and routine handling of commercial processes and planning tools
ability to prepare complex issues, figures and results in an understandable way and present them appropriately for the target audience

Job Responsibility

monitor key revenue positions, especially fare revenues, and ensure their correct booking
analyze revenue deviations and the underlying performance data and assess their impact on the transport contract – including identifying relevant action priorities and carrying out simulation calculations
create and process applications for compensation of the Deutschlandticket and the associated booking documents in the current year
take the lead in the correct billing with the transport authorities
responsible for commercial energy management for the entire company, develop suitable key figures and establish effective, action-oriented energy monitoring
in planning and forecast creation in TM1, take responsibility for revenues, performance data and energy
also support the optimization and further development of processes as part of the monthly, quarterly and annual financial statements

What we offer

16 free trips within Germany per year
further travel discounts such as DB job ticket for the daily commute
cheap travel options for family and friends
home office
flexible, individual working models
support through modern working forms, e.g. mobile working
flexible working time arrangements
support with time off or sabbaticals for caregivers

Fulltime

New

DevOps Engineer

DevOps Engineer position at Techland, a video game company known for franchises ...

Location

Poland , Warszawa; Wrocław

Salary:

Not provided

Techland S.A.

Expiration Date

Until further notice

Requirements

Professional experience on a similar position
Experience with scripting languages (eg: Python, PowerShell)
Experience with Unreal Engine tools and pipelines
Good problem solving skills
Good interpersonal and communication skills
Good command of English

Job Responsibility

Maintenance and development of build and deployment systems
Process automation (using Python)
Administering our version control system
user support (optimization and troubleshooting)
Supporting the submission process (packaging, documentation)
Conducting branching and integration tasks
Documenting and updating build and release processes

What we offer

A dedicated Buddy who will support you in your daily tasks
private medical care
life insurance
pro-health campaigns
gifts for different occasions
outstanding work atmosphere in a highly-skilled team of professionals
flexible working hours
no dress code
full support of the dedicated HR Business Partner
dedicated development budget for each employee

New

Writer

Techland is seeking a Writer to join the Narrative team in creating exciting, ac...

Location

Poland , Warszawa

Salary:

Not provided

Techland S.A.

Expiration Date

Until further notice

Requirements

Experience in writing narratives for video games
Being a true gamer at heart is an absolute must-have
Ability to work collaboratively and communicate effectively with different departments
Excellent command of both Polish and English
Creativity, independence, and the ability to work under time pressure

Job Responsibility

Designing narrative documentation, including creating story outlines, character descriptions, and world region overviews
Writing dialogues for the main storyline, side quests, and background conversations, in line with project documentation requirements
Designing, implementing, and developing dialogues in the proprietary C-Engine
Preparing and updating quest documentation (pitch, dialogue and scene scripts, quest character descriptions, etc.)
Collaborating creatively with the quest design team
Providing creative feedback on quest and scene creation and design within interdisciplinary quest teams
Participating in creative meetings aimed at developing quest documentation

What we offer

Private medical care
Life insurance
Pro-health campaigns
Gifts for different occasions
Outstanding work atmosphere in a highly-skilled team of professionals
Flexible working hours
No dress code
Full support of the dedicated HR Business Partner
Constant stream of company newsletters, PR & project updates
Dedicated development budget for each employee

New

Senior Manager Events and Catering

Assists the Assistant Director of Catering by providing support to the operation...

Location

United States

Salary:

85000.00 - 113000.00 USD / Year

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

High school diploma or GED
4 years’ experience in the event management, food and beverage, or related professional area
OR Bachelor’s degree from an accredited university in Hotel and Restaurant Management, Hospitality, Business Administration, or related major
2 years’ experience in the event management, food and beverage, or related professional area

Job Responsibility

Projects supply needs for the department
Applies knowledge of all laws as they relate to an event
Understands the impact of banquet operations on the overall success of a conference event and manages activities to maximize customer satisfaction
Adheres to and reinforces all standards, policies, and procedures
Maintains established sanitation levels
Manages departmental inventories and maintains equipment
Schedules banquet service staff to forecast and service standards, while maximizing profits
Assists team in developing lasting relationships with groups to retain business and increase growth
Manages department controllable expenses to achieve or exceed budgeted goals
Verifies that all banquet event orders (BEO’s) are developed and distributed according to established guidelines

What we offer

Relocation Assistance Available

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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