Associate Director, Clinical Project Management

Associate Director, Clinical Project Management

Galderma

Lausanne, Switzerland

Core Mission:

The Associate Director, Clinical Project Management (AD CPM) position is a key member of the Project Team and Project Strategy Team. The position plans and manages overall clinical operations for assigned global clinical programs including timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with Strategic & Innovation Group (SIG) strategies and goals. The AD CPM serves as a project team member and coordinates the overall clinical program activities with other functions (e.g. RA, CMC) including long-term, next stage planning and may supervise or instruct other CPMs as part of the overall clinical program.

Duties and Responsibilities:

  • Ability to manage complex phase 3 clinical trial programs. This includes but not limited to multiple phase 2/3 protocols in parallel;
  • Responsible for leading and managing the multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices;
  • Manages or instructs multiple CPMs assigned to protocols within the development program;
  • Responsible for the development of the Clinical Trial Outline (CTO) and Clinical Protocol through internal and/or external support;
  • Manages selection of study vendors for assigned studies;
  • Manages vendor(s) throughout the life of assigned clinical trial(s) and may serve on the Operations or Steering Committee overseeing overall activity;
  • Perform all CPM functions as outlined below.

In particular:

Plans and conducts Clinical Studies

  • Oversees the selection of countries and investigational sites with input from Clinical Development and vendors. Reviews and refines Clinical Operations Plans including monitoring and other plans. Works with clinical supplies to determine IP requirements. Plans and conducts investigator meetings, training sessions and KOL meetings as required. Reviews clinical regulatory documentation for the study submission including but not limited to CTA modules, IB, IMPD, EC, safety reports, labels. Mentors staff and serves as a resource for new employees.

Manages subcontractors (CROs, experts ...)

  • Works with Outsourcing manager to prepare Clinical-outsourcing specifications. Participates in the selection of CRO. Review the CRO contract including scope of services.

Quality and process

  • Contributes and initiates process improvement initiatives. Collaborate with other department members to promote harmonization of all processes and procedures. Involved in documents quality control.

Budget and planning

  • Establises project milestones, budgets, and timelines for the study conduct together with the study team. Establises a detailed planning of clinical project. Builds, follows-up and closes out study Budget following internal templates and instructions and according to the initially approved budget. On a regular basis, updates management with project milestones, costs, and projections for future activity (be able to provide various scenario/proposal/actions).

Project Team Representative (PTR)

  • Participates in the overall project planning, optimization and consolidation with the Project Team. Works closely with the Medical Experts and Clinical Scientist for the design of the clinical trials within the Project. Reports progress on deliverables to the Project Team and identifies variances and present solutions/alternatives. Is responsible for Operational aspects of the clinical project in terms of timelines, costs and resources.

Education and Training:

  • University degree, preferably in a biologic/scientific discipline.

Work Experience:

  • Minimum of 10 years progressive experience in clinical operations including 5 years of clinical project management or equivalent with Pharma/Biotech and/or CRO;
  • Systemic route of administration clinical trials experience required; pediatric, drug/device combination and biologics experience preferred;
  • Thorough understanding of country level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.

Language:

  • Must have fluent English speaking and writing skills.

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© EuroJobsites 2019

EuroJobsites is a UK 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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