Position Summary:

In support of clinical development programs, the Senior Manager of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities.  Implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required. 

Primary Responsibilities:

• Review and Interpretation of a clinical protocol or study overview:
  • Review and provide feedback during the development of the clinical protocol.
  • Calculate total demand and translation of total demand into a demand forecast.
  • Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
  • Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
  • Tracks expired materials and issues orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
  • Proposes and implements improvements to assure efficient clinical supply operations.
  • Investigates and resolves issues regarding inventory, shipments and returns.
  • Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
• Coordinates CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
• Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
• Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
• Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
• Reconciles and approves invoices
• Prepares reports to ensure accuracy and completeness of clinical supplies information.  Maintains departmental reports and files, updates SOPs and other projects as assigned

Education/Experience/Skills

• Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 4-6 years' experience in pharmaceutical development focused on clinical trial materials
• The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
• Proven project management skills
• Ability to handle multiple projects simultaneously
• Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
• Good understanding of IRT system build-up and user testing
• Good negotiating skills with customers and suppliers
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Good organizational and documentation skills
• Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
• Excellent written and verbal communication skills
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
• Skilled at creating a cooperative team environment
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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The Opportunity:

The Qualified Person (QP) holds ultimate responsibility for the certification and release of medicinal products in accordance with EU GMP, Directive 2001/83/EC, Dutch pharmaceutical legislation, and applicable Marketing Authorisations.

The role provides independent, authoritative quality leadership across site operations and serves as a key member of the site leadership team, ensuring patient safety, product quality, regulatory compliance, and reliable supply.

In addition to batch release accountability, the QP provides strategic oversight of the Pharmaceutical Quality System, partners closely with senior stakeholders across Quality, Technical Operations, Supply Chain, and Regulatory Affairs, and represents the site in interactions with Health Authorities.

• Regulatory Accountability & Product Release

  • Act as the legally registered Qualified Person with full authority for certification and release of clinical and commercial medicinal products.

  • Ensure batch certification in compliance with EU GMP, Directive 2001/83/EC, national legislation, EU GMP Annex 16, the applicable Marketing Authorisation, and approved regulatory dossiers (e.g., MA, IMPD), and applicable authorisations.

  • Exercise independent decision-making authority, including batch rejection and escalation when required.

  • Ensure timely batch disposition aligned with supply commitments and compliance requirements.

  • Responsible for the certification and release of Investigational Medicinal Products (IMPs) in accordance with EU Clinical Trial Regulation and EU GMP Annex 13, including oversight of randomisation, blinding, labelling, comparators, and clinical supply chain integrity.

  • Maintain QP oversight of the end‑to‑end GMP supply chain, including qualification, approval, and ongoing monitoring of contract manufacturers, testing laboratories, API suppliers, and logistics providers.

• Quality System Leadership

  • Provide oversight of the Pharmaceutical Quality System, ensuring inspection readiness and regulatory alignment.

  • Oversee deviations, CAPAs, change controls, investigations, complaints, and recalls.

  • Approve critical GMP documentation including SOPs, validation documentation, and quality agreements.

  • Ensure that third‑country manufacturing sites comply with EU GMP requirements, including audit strategy, GMP equivalence assessment, and importation controls.

  • Provide QP oversight of data integrity governance across GMP processes and computerized systems, ensuring adherence to ALCOA+ principles, validated system use, appropriate audit trails, and timely escalation of data integrity risks that may impact batch certification or regulatory complian

  • Oversee continued process and product verification activities, including stability programs, ongoing trend analysis, and Product Quality Reviews (PQR/APQR), ensuring that emerging quality risks are identified, assessed, and managed proactively throughout the product lifecycle.

• Strategic & Cross-Functional Leadership

  • Act as a strategic quality partner to site and functional leadership.

  • Lead quality risk assessments related to manufacturing operations and change initiatives.

  • Mentor QA professionals and support QP succession and capability building.

  • Embed a proactive quality culture across the organization.

• Regulatory & External Representation

  • Serve as primary QP representative during inspections and Health Authority interactions.

  • Lead inspection readiness and coordinate regulatory responses.

  • Maintain oversight of recall activities.

• Performance, Governance & Escalation

  • Define and present quality KPIs, trends, and risk assessments to senior management.

  • Drive continuous improvement using data-driven insights and benchmarking.

  • Provide escalation support during critical quality events.

  • Act independently in the execution of QP duties, maintain direct access to senior management for escalation of critical quality, compliance, or patient safety risks, and ensure that QP certification decisions are not compromised by commercial or supply pressure.

  • Maintain an effective interface with Pharmacovigilance to ensure timely assessment and escalation of quality‑related safety signals, quality defects, recalls, and Rapid Alerts, in accordance with regulatory expectations and patient safety requirements.

Required Skills, Experience and Education:

• Master's degree in Pharmacy, Chemistry, Biotechnology, or relevant scientific discipline.

• 9+ years experience working in quality related roles with increasing responsibility.

• Eligibility for registration as a Qualified Person under Dutch pharmaceutical legislation.

• Extensive experience as a Qualified Person with direct batch release accountability.

• Deep working knowledge of EU GMP and relevant regulatory frameworks.

• Proven inspection experience and senior stakeholder engagement capability.

• Fluency in English; Dutch language skills are an advantage.

• Risk-based, pragmatic mindset balancing compliance and supply reliability.

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Are you a CRA looking for the best of both worlds?

Would you like to work directly with a single sponsor while still enjoying the stability, global reach, and career development opportunities that come with working for a leading CRO? Our team calls it the best of both worlds — and we think you’ll agree.

ClinChoice is a rapidly growing global contract research organization. We’re currently expanding our CRA network in the Netherlands and looking for talented Clinical Research Associates (CRA II and Senior CRA) interested in partnering with some of the world’s leading pharmaceutical companies in the field of biomedicine.

If that sounds like you, we encourage you to submit your resume via our website — we’d love to hear from you!

Position Overview – Clinical Research Associate
As a CRA, you’ll manage clinical study activities across multiple sites within one or more projects, with a focus on medical devices. You will oversee site performance, conduct company-initiated clinical studies, and ensure high-quality deliverables through site visits, monitoring, and effective communication.

Key Requirements:

• Willingness to travel to sites and surrounding countries (50-80% travel).

• Fluent in Dutch (required for work in the Netherlands).

• Prior experience in monitoring clinical trials and site management.

Join a dynamic, global team that values growth, collaboration, and making a difference in clinical research.

Skills and Qualifications:

• Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Up to 8 years of experience as a CRA.
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements.
• Sound knowledge of medical terminology.
• Fluent in English and local language(s).
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).

Education and Experience:

• A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science, a Masters or PhD/MD/PharmD.
• At least 4 plus years of onsite monitoring experience is required.
• Previous medical device monitoring experience is required. Therapeutic area experience in neuro- or cardiovascular domain is also required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background – a plus.
• Languages: Be able to converse and monitor in English and Dutch. Must be able to converse and understand the documentation, monitoring, etc. in a reasonably confident manner to monitor in that.
• Ability to travel up to 80% of time.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Senior Clinical Research Associate, Senior CRA, Freelance, Self-employed, Contract, Site Management, Monitor, Monitoring, Complex Trials, Medical Devices, Cardiology, Neurology, Open to Travel, Submissions, Ethics, Contract Research Organisation, CRO

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