CrawlJobs Logo
Proclinical Logo Proclinical · Research and Development

Senior Site Director, Clinical Operations

Belgium, Brussels · Job Posted March 20, 2026
Apply Position
Job Link Share

Job Description

Proclinical is seeking a Site Director, Clinical Operations to be responsible for overall clinical site management. This includes site identification, feasibility, pre-study site evaluation, study start-up, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures, ICH-GCP guidelines and all applicable regulatory requirements. Using available systems and tools, you will monitor and oversee site activities both onsite and remotely to ensure that patients' rights, safety and well-being are protected and that the data generated at sites are complete and accurate. You will be accountable for patient enrolment and overall delivery of high-quality patient data in established timelines for all designated sites in Belgium and/or assigned region.

Job Responsibility

  • Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
  • Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
  • Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
  • Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
  • Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
  • Develop and cultivate strong site relationships and ensure continuity of site relationships
  • Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
  • Identify, assess, escalate and resolve site performance or quality issues in a timely manner
  • Complete feasibility and site identification activities for new clinical studies
  • Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
  • Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
  • Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
  • Responsible for the development of site-specific recruitment, retention and follow-up plans
  • Facilitate and support investigator site audits and/or inspection activities as needed
  • Perform remote data review and query resolution for designated sites
  • Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
  • Contribute to the review of company's systems and procedures as needed

Requirements

  • Bachelor's Degree in a Life Science discipline required
  • Bachelor's Degree in Nursing or RN a plus
  • Proven working years of direct site monitoring experience required
  • Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required
  • Thorough understanding of EMA, ICH and GCP guidelines and applicable local regulations
  • Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes
  • Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle
  • Detail-oriented, organized and committed to quality and consistency
  • Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
  • Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs
  • Experience and proven proficiency in CTMS and eTMF systems preferred
  • Must be willing and able to travel within EU area, as required

Nice to have

  • Bachelor's Degree in Nursing or RN
  • Experience and proven proficiency in CTMS and eTMF systems
Proclinical - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Site Director, Clinical Operations

8 matching positions

Us Country Head, Global Site & Study Operations Senior Director

Provide strategic and operational leadership for all study and site execution wi...
Location
Location
United States
Salary
Salary:
228624.00 - 265674.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree & 5 years of clinical execution experience or equivalent
  • Master's degree & 9 years of clinical execution experience or equivalent
  • Bachelor's degree & 11 years of clinical execution experience or equivalent
  • In addition to meeting at least one of the above requirements, you must have a minimum of 5 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
Job Responsibility
Job Responsibility
  • Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography, ensuring delivery of the clinical portfolio in alignment with global study strategies, regulatory requirements, and Amgen quality standards
  • Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography, delivering start-up, enrolment, retention, data quality, and patient safety outcomes in compliance with local regulations and global strategies
  • Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection, aligned to global portfolio priorities and regional strengths
  • Lead, line-manage, and develop the Country/Hub team, ensuring clear direction, strong performance, capability development, and succession planning to deliver portfolio and organizational objectives
  • Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles, working closely with global partners to match capacity and capability to portfolio demand
  • Drive site engagement through a clearly differentiated Amgen site experience strengthening investigator and site relationships through strong leadership, compliance, innovation, and collaboration with global study teams
  • Oversee country-level financial and operational management, including budgets, forecasting, vendor oversight, and efficient allocation of resources to ensure accountability and value delivery
  • Lead country governance and risk management, including chairing the Country Management Team (CMT),representing the country in senior governance forums, and managing risks, issues, and escalation to protect quality and delivery
  • Ensure regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs, and local regulatory requirements.
What we offer
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
Read More
Arrow Right

Senior Director of Clinical Operations - sutacimig program

Hemab Therapeutics is seeking a Senior Director of Clinical Operations — a high-...
Location
Location
United States , Boston
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree or higher in life sciences, biology, or related field
  • Strong command of ICH/GCP and international regulatory requirements
  • 15+ years of clinical operations/clinical program management experience in pharmaceutical or biotech
  • Experience in rare disease, hematology, or bleeding disorders preferred
  • 10+ years in a management or functional leadership role
  • Demonstrated ability to identify and implement operational process improvements
  • Proven track record of on-time, on-budget trial delivery in complex global programs
  • Excellent cross-functional collaboration and executive communication skills
  • Deep expertise in early and late-phase trial design and execution
  • Experience managing and optimizing CRO and vendor relationships
Job Responsibility
Job Responsibility
  • Drive innovative, creative and efficient trial design and optimization
  • Accountability for trial start, recruitment, enrollment and end to end execution
  • Represent Clinical Operations on the Asset Team and Clinical Strategy Subteam, contributing strategic and operational input on the sutacimig clinical development plan
  • Own end-to-end operational execution of clinical trials from protocol finalization through clinical study report
  • ensuring delivery on time, within budget, and to the highest quality standards
  • Drive rigorous planning and accountability across all functions: define milestones, manage risks proactively, and resolve operational issues with urgency and precision
  • Build and evolve fit-for-purpose processes, standards, and operating procedures that scale with the organization and reflect industry best practice
  • Establish and maintain transparent, data-driven reporting mechanisms to keep executive leadership and cross-functional teams fully informed on trial status, risks, and performance metrics
  • Lead budget ownership across the program including forecasting, tracking, and actively managing spend to ensure financial discipline without compromising quality or speed
  • Proactively identify and implement process innovations including novel trial designs, technology platforms, and decentralized/hybrid trial elements to accelerate timelines and improve patient access
  • Fulltime
Read More
Arrow Right

Executive Director, Global Clinical Operations

We are seeking an Executive Director, Global Clinical Operations, (GCO), who wil...
Location
Location
United States
Salary
Salary:
285000.00 - 320000.00 USD / Year
apogeetherapeutics.com Logo
Apogee Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BS in life sciences or equivalent
  • Minimum 20 years of clinical research experience, including at least 5 years leading global projects from inception to completion
  • Minimum of 7 years line management experience
  • Minimum of 3 years’ experience in Biotech industry strongly preferred
  • Significant knowledge of pharmaceutical industry, drug development and regulatory processes
  • Experience developing all clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, etc.
  • Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
  • Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally
  • Excellent communication skills with ability to develop strong relationships and present to a variety of stakeholders and tailor message accordingly
  • Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally
Job Responsibility
Job Responsibility
  • Manage and plan CTO resourcing for assigned programs
  • Lead, build and mentor CTO team supporting assigned program(s)
  • Serve as a member on Clinical Operations Leadership Team (COLT)
  • Create and support implementation of Clinical Operations processes, platforms and/or systems
  • Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs
  • Clinical operations representative on Program Teams (PT)
  • Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions
  • Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans
  • Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy
  • Strong collaboration and partnership with cross functional colleagues globally
What we offer
What we offer
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve
  • Fulltime
Read More
Arrow Right

Director Global Site & Study Operations

In this vital role, you will provide strategic and operational leadership for st...
Location
Location
United Kingdom , Uxbridge; London; Cambridge
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree educated
  • Clinical trial execution experience and previous people leadership managing teams, projects, or resources
  • Previous experience in life sciences or a related field, including biopharmaceutical clinical research
  • Experience working with or overseeing clinical research vendors (e.g., CROs, central labs, imaging)
  • Strong experience leading clinical operations across a country or region, with knowledge of local regulatory requirements
Job Responsibility
Job Responsibility
  • Owning end-to-end study and site execution, including start-up, enrollment, retention, data quality, and patient safety
  • Advising on country commitments, feasibility, site selection, and study placement aligned with portfolio priorities
  • Leading, developing, and resourcing country or hub teams to meet current and future portfolio needs
  • Driving strong investigator and site engagement through a differentiated Amgen site experience
  • Managing country-level budgets, forecasting, and vendor performance to ensure efficient use of resources
  • Leading country governance and risk management, including chairing the Country Management Team and representing the country in senior forums
  • Ensuring regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs
What we offer
What we offer
  • Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Read More
Arrow Right

Director Global Site & Study Operations

In this vital role, you will provide strategic and operational leadership for st...
Location
Location
United Kingdom , Cambridge; London; Uxbridge
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree educated
  • Clinical trial execution experience and previous people leadership managing teams, projects, or resources
  • Previous experience in life sciences or a related field, including biopharmaceutical clinical research
  • Experience working with or overseeing clinical research vendors (e.g., CROs, central labs, imaging)
  • Strong experience leading clinical operations across a country or region, with knowledge of local regulatory requirements
Job Responsibility
Job Responsibility
  • Owning end-to-end study and site execution, including start-up, enrollment, retention, data quality, and patient safety
  • Advising on country commitments, feasibility, site selection, and study placement aligned with portfolio priorities
  • Leading, developing, and resourcing country or hub teams to meet current and future portfolio needs
  • Driving strong investigator and site engagement through a differentiated Amgen site experience
  • Managing country-level budgets, forecasting, and vendor performance to ensure efficient use of resources
  • Leading country governance and risk management, including chairing the Country Management Team and representing the country in senior forums
  • Ensuring regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs
What we offer
What we offer
  • Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Read More
Arrow Right

Senior Director of Regional Healthcare FM Operations

We're seeking an exceptional healthcare facilities management leader to run our ...
Location
Location
United States , Seattle
Salary
Salary:
185000.00 - 200000.00 USD / Year
jll.com Logo
JLL
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors degree in Engineering or technical disciplines in Plant Operations, HVAC, Electrical, Plumbing, or related field AND minimum nine (9) years of experience in Engineering, Plant Operations, HVAC, Electrical, Plumbing, or directly related field OR Minimum twelve (12) years of experience in Engineering, Plant Operations, HVAC, Electrical, Plumbing, or a directly related field
  • 8-12 years of progressive healthcare facility operations or building engineering experience
  • 5-7 years in leadership roles managing multiple sites and teams
  • Experience with P&L responsibility and budgets over $20M+
  • Proven track record in hospitals, medical office buildings, or integrated healthcare systems
  • Strong leadership presence with ability to work with senior executives
  • Experience mentoring and leading teams while building positive, high-performing cultures
  • Excellent communication skills for executive-level presentations
  • Ability to represent the organization as a strategic partner
  • Advanced facility operations expertise and preventive maintenance programs
Job Responsibility
Job Responsibility
  • Lead facility operations across a diverse healthcare portfolio including hospitals, medical office buildings, clinics, and administrative campuses
  • Partner directly with senior client leadership to align operations with clinical care priorities and patient experience goals
  • Manage a large annual operating budget
  • Oversee critical healthcare facility systems (central plant, HVAC, medical gas, emergency power, life safety)
  • Ensure regulatory compliance (Joint Commission, OSHA healthcare standards, infection control)
  • Lead a regional team of site operations managers and engineering staff
  • Drive financial performance through P&L accountability, vendor management, and continuous improvement initiatives
What we offer
What we offer
  • 401(k) plan with matching company contributions
  • Comprehensive Medical, Dental & Vision Care
  • Paid parental leave at 100% of salary
  • Paid Time Off and Company Holidays
  • Early access to earned wages through Daily Pay
  • Fulltime
Read More
Arrow Right

Director / Senior Director, Global Logistics, Warehousing and Trade Compliance

The Senior Director, Global Logistics, Warehousing and Trade Compliance is respo...
Location
Location
United States , Cambridge, MA / Durham, NC
Salary
Salary:
210000.00 - 320000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Business, Supply Chain, Engineering, Life Sciences, or related field
  • MBA or Master’s degree preferred
  • 18+ years of progressive experience in global logistics, warehousing, supply chain, and/or trade compliance within biotech, pharmaceutical, or other highly regulated environments
  • Proven senior leadership experience managing complex global networks of internal operations and external partners (CMOs, CDMOs, 3PLs)
  • Working knowledge of global trade compliance regulations, including U.S. Customs and relevant international authorities
  • experience with permits, licenses, duties, VAT, sanctions, and duty savings strategies
  • Demonstrated expertise in pharmaceutical cold chain logistics (ambient, refrigerated, frozen, ultra-low temperature) across R&D, clinical, and commercial programs
  • Strong strategic and operational leadership skills, with the ability to influence cross-functional and matrixed stakeholders globally
  • Excellent analytical, communication, and decision-making skills in high-complexity environments
  • Financial acumen including budgeting, cost control, and KPI management
Job Responsibility
Job Responsibility
  • Global Logistics: Provides operational and strategic leadership for all R&D, Clinical, and Commercial shipments
  • Serves as subject matter expert for ambient, low‑temperature, and ultra‑low‑temperature cold chain systems, including shipping systems qualification and lane validation, in support of CMC development and commercialization
  • Supports Commercial Patient Operations for Risto-cel Patient shipments
  • Warehousing: Leads internal warehouse operations and the global 3PL network supporting storage, inventory management, kitting, and production support for critical raw materials, drug substance, and drug product
  • Ensures inventory accuracy, material availability, and scalable warehouse capabilities aligned with clinical and commercial demand
  • Trade Compliance: Acts as the enterprise risk leader for global trade compliance, ensuring compliance with international, federal, and state import/export laws and regulations
  • Leads the development and governance of compliant, efficient trade processes across North America, Europe, and Asia‑Pacific regions, and serves as the primary interface with customs brokers, government agencies, and external auditors
  • Champions a culture of compliance while enabling business agility and uninterrupted supply
  • Supports Market Access team for any commercial trade or channel distribution aspects
  • Strategy & Leadership: Develop and execute global logistics, warehousing, and trade compliance strategy to support R&D, clinical trials, and commercial operations
  • Fulltime
Read More
Arrow Right

Senior Clinical Research Associate/Clinical Research Associate II - Oncology

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...
Location
Location
United States
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
  • Preferred therapeutic experience in Oncology
  • Global clinical trial experience preferred
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
  • Must be fluent in English and in the native language(s) of the country they will work in
  • Travel (60-80%) within area is required
  • 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
Job Responsibility
  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor 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
What we offer
What we offer
  • Flexible work arrangements
  • Career growth and development
  • Supportive and inclusive environment
  • Diverse therapeutic areas and project exposure
  • Advanced Technology
  • Fulltime
Read More
Arrow Right