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Associate Project Manager

hace 1 mes

Madrid, Madrid, España Pharmiweb A tiempo completo

We are seeking a highly skilled Associate Project Manager to join our team at Pharmiweb. The successful candidate will be responsible for leading and contributing to the preparation of delegated study documents, maintaining and facilitating interactions with internal and external functions, and ensuring efficient study delivery to time, costs, and quality objectives.

Key Responsibilities:

  • Leads/contributes to the preparation of delegated study documents and external service provider related documents.
  • Maintains and facilitates interactions with internal and external functions to ensure efficient study delivery.
  • Contributes to the planning and conduct of internal and external meetings.
  • Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers.
  • Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
  • Ensures that all study documents in scope of global associate project manager responsibilities are complete and verified for quality in Trial Master File.
  • Supports Global Study Directors and/or GSAD with budget management, such as external service provider invoice reconciliation.
  • Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
  • Supports Global Study Directors and/or GSAD with overall project management as per agreed delegation.
  • For outsourced studies, supports Global Study Directors and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed 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.

Requirements:

  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
  • Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
  • Vendor management experience.
  • Knowledge of clinical development/drug development process in various phases of development and therapy areas.
  • Excellent knowledge of international guidelines ICH/GCP.
  • Excellent communication and relationship building skills, including external service provider management skills.
  • Good project management skills.
  • Demonstrated ability to collaborate as well as work independently.
  • Demonstrated leadership skills.
  • Computer proficiency, advanced.

Location:

Poland, Spain, UK, Bulgaria.

Background:

Clinical Research background with experience in Global Clinical Trial Administrator, Project Specialist supporting the global clinical study team, CRA, In-House CRA.