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Project Manager/Sr PM (Poland) - sponsor-dedicated, oncology Ph I

Employer
Syneos Health
Location
Home Based, POL
Salary
Competitive
Start date
26 Sep 2021
Closing date
19 Oct 2021

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Job Details

Project Manager / Sr PM - sponsor-dedicated, one or max two projects in oncology, Ph I

(Senior) Project Manager will be responsible for execution and delivery of assigned studies across Europe to time, budget and quality as defined in protocol as well as in European regulations, ICH GCP/IND guidelines and the internal company's procedures.
(Senior) Project Manager will be responsible for matrix leadership and project management including oversight of the countries management and monitoring activities across Europe.
(Senior) Project Manager will be a point of contact for Global Study Team, European Team, Medical Advisors, CRAs, Sr CRAs, Start up Specialist and other Staff aligned to the studies.
(Senior) Project Manager possess a high level of clinical expertise and is involved in the mentoring and training of European staff and sharing best practices across region.
(Senior) Project Manager will be a crucial link between the regional, local and global teams and external stakeholders based in many countries in Europe.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Main diuties:
  • Responsibility for the discipline of risk-based planning, organizing and managing risks/contingency planning for each stage of the study to bring about the successful completion of specific project aims in accordance with defined quality and time- based metrics
  • Responsibility for an appropriate issue escalation, communication and follow-through within countries and above countries, reporting status/issues effectively to Senior Management.
  • Ability to ensure the quality and integrity of studies conducted in European countries by taking appropriate business management activities as agreed with Senior Management and Quality Management
  • Responsibility for a study oversight: coordinating internal and external operational activities, maintaining clear visibility to sites' progress and issues, reviewing protocol deviations and metrics.
  • Ability to develop and maintenance of regional study plan and forecast, including budgets, milestones, timelines, quality, and risk planning.
  • Responsibility for an appropriate trainings of in-countries staff assigned to the studies and delivering operational aspects at Investigator Meetings, Monitor Meetings and country trainings
  • Ability to lead countries/sites feasibility, preparation of pre-sites selection in cooperation with Medical Advisors and Regional Management.
  • Ability to drive trial start up by coordinating preparation of CPC by respective members and tracking progress of start up milestones ( Feasibility, FPA, CPC, SIVs, FPFVs)
  • Responsible for regional recruitment at the study level, including responsibility for forecasting, setting up contingency plans to ensure a target is achieved.
  • Responsibility for reviewing and approving all MVRs for the studies within agreed timelines and focusing on any trends or issues.
  • Ability to specify and review study monitoring tracking tools, monitoring key risk and performance indicators and other reports.
  • Ability to build close working relationships with key internal and external stakeholders ( External Experts, Clinical Investigational Staff, Ethics Committees, Regulatory Authorities, CRO and other Vendors )
  • Ability to work effectively in a remote environment
  • Ability to travel as required ( CMVs, Booster Visits, Investigator Meetings, Assessments, Inspections)
What we're looking for
  • Advanced degree ( e.g MS, PhD, MD, PharmD) in a field of Life Science, Medicine, Clinical Research, Pharmacy.
  • A minimum 5+ years of clinical research experience, in planning/executing and monitoring clinical trials.
  • At least 3-4 years of experience in a regional/global project management role.
  • Experience in oncology is preferred.
  • Strong project management mindset, and ability to work and lead in a matrix team environment involving both internal and external Partners.
  • Strong skills and experience in project management (including scope, budget, timeline, people management, and use of associated tools and support )
  • Excellent organizational skills, with ability to prioritize and work effectively in a complex matrix environment
  • Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

#LI - MB1

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