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Project Manager II for Early Phase (Poland, Bulgaria, Hungary, Spain or Portugal)

Project Manager II for Early Phase (Poland, Bulgaria, Hungary, Spain or Portugal)

Syneos HealthWarszawa, Województwo mazowieckie, Polska
23 days ago
Job description

Overview

Project Manager II for Early Phase (Poland, Bulgaria, Hungary, Spain or Portugal)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Responsibilities

  • Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOPs, and regulatory requirements.
  • Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
  • Lead project team to ensure quality, timelines and budget management.
  • Accountable for the financial performance of each project. Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
  • Ensure studies are conducted in compliance with GCP, relevant SOPs and regulatory requirements. Accountable for all project deliverables for each project assigned.
  • Responsible for quality and completeness of TMF for assigned projects.
  • Accountable for maintenance of study information on a variety of databases and systems.
  • Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementation of project plans.
  • Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management.
  • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
  • Develops strong relationships with current clients to generate new and / or add-on business for the future.
  • May participate in bid defense meetings where presented as potential project manager.
  • May be required to line manage other project management team members and clinical monitoring staff.

Qualifications

  • Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
  • Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice / ICH guidelines and other applicable regulatory requirements.
  • Strong organizational skills.
  • Strong ability to manage time and work independently.
  • Direct therapeutic area expertise.
  • Ability to embrace new technologies.
  • Excellent communication, presentation, interpersonal skills, both written and spoken.
  • Ability to travel as necessary (approximately 25%).
  • Seniority level

  • Mid-Senior level
  • Employment type

  • Full-time
  • Job function

  • Project Management and Information Technology
  • We are always excited to connect with great talent. This posting is intended for a (possible) upcoming opportunity rather than a live role. By expressing your interest, you’ll be added to our talent pipeline and considered should this role become available.

    Get to know Syneos Health

    Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

    No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    Additional Information : Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion. Equivalent experience, skills, and / or education will also be considered. The Company will determine what constitutes as equivalent qualifications. This posting reflects statutory and regulatory compliance as required in the jurisdictions in which we operate.

    Summary : Roles within Clinical Project Management are responsible for planning, directing, creating and communicating clinical study timelines, gathering input from cross-functional teams, and ensuring deliverables align with SOPs, GCP, and country regulations.

    #J-18808-Ljbffr

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    Project Manager • Warszawa, Województwo mazowieckie, Polska

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