Clinical Project Manager

Clinical Project Manager

Biocartis

Mechelen, Belgium

The Clinical Project Manager (CPM) plans and manages overall clinical operations for assigned global clinical trials/projects as part of product development projects, for CE-IVD as well as US FDA and other global registrations. The CPM outlines the clinical evidence strategy, in collaboration with the multifunctional project teams.

He/she serves as a core team member of the IVD development team, providing scientific expertise and leads the execution of clinical evidence studies to ensure on­ time delivery of clinical development deliverables. This includes timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, regulatory requirements and ICH/GCP guidelines and in alignment with Biocartis business strategies and goals.

Accountabilities

  • Designs the clinical development strategy in conjunction with the multifunctional project team.
  • Prepares clinical study plans that meet product design goals, regulatory requirements, business needs according to Biocartis procedures. Acts as point of contact to external stakeholders (i.e. Pharma & other partners) to ensure alignment on all aspects of clinical study design and execution.
  • Manage all aspects of contracted clinical service providers (i.e. CRO’s, etc.) and acts as the point of contact for all contracted clinical service providers.
  • Proposes and negotiates budgets for clinical studies and external clinical resources.
  • Works with the Biostatistician to define the study design and statistical analysis of clinical data. Ensures site compliance with clinical study protocol and ICH/GCP guidelines.
  • Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
  • Participates in assessing performance data generated by investigational sites. Ensures data integrity through completeness and accuracy.
  • Complies with all policies, established procedures, and regulations related to clinical research.
  • Actively participates as member of cross-functional project teams, ensures cohesion between analytical and clinical activities, and lends support as needed across to cross-functional validation activities.
  • Participates in assessing performance data generated by cross-functional teams.
  • Acquires understanding of the Idylla platform principles and “hands-on” knowledge/skills in performing assigned assays.
  • Provides clinical support to (clinical) feasibility studies.
  • Maintains accurate and timely sponsor/site correspondence and communication.
  • Reviews data, prepares, and presents clinical data reviews and summaries.
  • Responds to audit and data queries.
  • Prepares and presents project progress reports to keep management and team informed.
  • Participates in preparation of the clinical sections of regulatory submissions packages and assists in responding to requests from the regulator regarding the clinical study.

Profile requirements

  • Advanced degree in a scientific field (Master or PhD preferred) or equivalent through experience.
  • 2-5 years of relevant experience working in Clinical Operations in the pharmaceutical/biotech industry/medical device and/or a CRO.
  • CRA experience is preferred.
  • Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) and all aspects of trial and vendor management perferred.
  • High degree of competence in all aspects of a clinical research program is required.
  • Strong practical knowledge of compliance and regulatory environments (US, EU and rest of world) is required
  • Experience in Medical Device and Companion Diagnostics projects is an asset
  • Experience in IVD (clinical) development and validation studies is required
  • Proven experience with KOL-, CRO- and international project management is required
  • Experience in organizing and executing clinical studies for regulatory submissions
  • Scientific and technology background in molecular diagnostics
  • Strong working knowledge of GCP and IHC guidelines
  • Excellent technical writing and good documentation skills
  • Affinity with clinical drug development is an asset
  • Planning & organization - Time & priority management: plans activities effectively with respect for priorities and deadlines; Self-starter & significant degree of autonomy;
  • Adaptability to change – Adapting to change: accepts and implements change and adapts, even in difficult situations;
  • Resilience – Continues to perform effectively under time pressure and in the face of disappointment, adversity and opposition; Able to work under pressure and have a flexible approach;
  • Communication & influencing – Communicates with persuasion: presents, explains and defends a complex message in a clear and concise way and persuades different stakeholders;
  • Strategic thinking - Understands and applies Biocartis vision and strategy and aligns actions with it;
  • Diplomatic and able to maintain secrecy concerning strictly confidential information;
  • Travel, some international approx. 40%.

Legislation and regulation:

  • Experience in application of international regulatory and quality guidelines for clinical laboratory methods (ISO, FDA, CLSI).
  • GLP and GMP working knowledge.

PC skills:

  • MS Office (Word, Excel, Powerpoint, Outlook).
  • eDC and eTMF systems is an asset.

Languages:

  • Fluent in English, both written and spoken.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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