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CLINICAL PROJECT MANAGER από την εταιρεία Creative Pharma Services S.A

Τελευταία ημέρα για να κάνετε αίτηση
Πλήρης Απασχόληση
Chalandri

Περιγραφή Θέσης

Creative Pharma Services SA is a customer oriented Contract Research Organization offering services to the Pharmaceutical, Biotechnology and Medical Devices Industry. Our mission is to meet customer needs, while maintaining strict confidentiality and professionalism.

The quality of our people is the cornerstone of Creative Pharma Services. Our Team consists of passionate, outcome-oriented, collaborative, innovative, enthusiastic and with outstanding academic background people and that is our greatest asset. Due to our constant growth we are currently seeking for a:



CLINICAL PROJECT MANAGER


Main Responsibilities

The Clinical Project Manager will have full accountability of all assigned global/local clinical trial(s) at country level including adherence to quality, timelines, budgets, resources, and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines. Responsibilities also include providing matrix management of functional area representatives to the cross-functional clinical project teams and supporting the Clinical Team Leader. Specifically:

  • Overall coordination and management of clinical trials from startup to closeout
  • Budget and Timelines/Milestones Management
  • Vendor Management. Develop outsourcing specifications on vendor requests for proposal and scope of work agreements
  • Work closely with external and internal stakeholders in project initiation phase to define scope, schedule, cost and budget 
  • Provision of support and expertise for regulatory, ethical and administrative submissions
  • Overview of Contract Negotiations until full contract execution
    • Active conduction of risk management activities (assessment, measurement and mitigation) on an ongoing basis in order to ensure overall delivery at the country and site level (time, quality, cost).
    • Collaboration in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up.
    • Identification of areas of best practice and contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function.
    • Demonstrate flexibility, positive thinking, problem solving attitude and an appetite for numerous projects of varied shape and size
    • Promote a healthy working environment by leading projects’ teams by example
    • Communicate effectively with all other study team members at local & global level
  • Coaching and provision of indirect line management and support to local clinical team (SSUS, CTAs, CRAs)
  • Identify and provide solutions to clinical development issues or risks
  • Participation as appropriate in internal and external audits


Απαραίτητα Προσόντα

  • Life Sciences or related degree
  • Minimum 4 years of experience in interventional clinical trials
  • Thorough understanding of country level regulations, ICH and GCP guidelines
  • Experience in project organizational structure development, team/resource management and stakeholder management
  • Strong influencing and persuasion skills
  • Balance among drive for results, customer focus and realistic goal/milestone setting
  • Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
  • Fluency in written and oral English
  • Computer literacy
  • Ability to lead a cross-functional team in a matrix environment
  • Strong interpersonal, negotiation, verbal and written communications and presentation skills
  • Proven complex problem solving and decision making skills
  • Strong leadership, communication, management and organizational skills, conflict resolution, and team building skills
  • Line management experience will be a plus, but not prerequisite


What is offered

Creative Pharma Services is offering a competitive remuneration package according the Industry’s standards. Nonetheless, we are also proud at Creative Pharma Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast paced working environment, but also an employer that invests in people’s potential and growth.

By sending your CV to us you accept our “Privacy Statement and Terms for submitting your Curriculum Vitae", which is available at http://www.creativephs.com/en/data-protection-policy




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