Global Study Leader

2 tygodni temu

Kraków, Lesser Poland Ryvu Therapeutics Pełny etat

Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small molecule therapies that address emerging targets in oncology.

The main purpose of this role is to lead the global clinical study in cooperation with internal and external stakeholders. Ensuring patient safety, data integrity, and regulatory compliance. Responsibilities include leading cross-functional teams, managing timelines and budgets, supporting patient recruitment, and coordinating with medical and regulatory teams.

KEY RESPONSIBILITIES

  • Responsible for delivery of all aspects clinical studies in oncology and heamatology area. Serve as the primary study contact for the Ryvu management and the study team members.
  • Ensure patient safety, data validity/integrity, regulatory acceptance and/or to Ryvu business reputation remain unbiased on any stage of the study conduct.
  • Lead and maintain oversight for cross-functional teams comprised of internal and external partners.
  • Ensure studies are progressed as planned, driving achievement of milestones according to timelines, budget and quality standards.
  • Support patient recruitment process
  • Develop and follow the most efficient operating model for investigator initiated/supported/collaborative studies, to manage appropriately the risks linked to investigator initiated/supported/collaborative studies.
  • In partnership with the Medical Monitor/Medical Director and all study team members, accountable for the co-ordination of full, feasible study protocol development that can be feasibly implemented in the clinical and regulatory environment of participating regions to provide quality data and ensure timely study delivery.
  • In partnership with Regulatory team supports regulatory strategy for the study.
  • Lead escalation and resolution of any issues with CRO/ vendors/ site/ country team performance raised by the study team.
  • Lead key discussions with CRO suppliers to ensure appropriate expectations have been set and company/CRO are aligned on delivery strategy
  • Accountable for study delivery strategy (e.g. country selection, diversity, patient engagement strategy and other stakeholders
  • In cooperation with Clinical Vendor Manager ensures adherence to vendors Oversight Plans as appropriate
  • Together with Clinical Vendor Manager ensures all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
  • Manage internal and external stakeholders through appropriate engagement and communication
  • Accountable for leading the identification of overall study-level risk management activities and ensure mitigation strategies are implemented effectively.
  • Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
  • Ensure studies are inspection-ready at all times, according to ICH-GCP, Ryvu SOPs and relevant policies/guidelines aswell ensure all the study team members are adequately trained (and training is documented) to conduct the study (e.g. protocol, manuals, tools, etc.).
  • Coordinate all start up activities and ensures that timely Ethics Committees/Competent Authorities submissions are addressed.
  • Prepare and monitor clinical activity timelines and metrics. Ensure regular project review, and reviews monitoring visit reports (task can be delegated).
  • Prepare, organize and hold an internal study team meetings and study team meetings with supporting vendors (as required).
  • Timely set up, organization, content and quality of the relevant sections of the Trial Master File.
  • Participates in an ad hoc level meeting when required to provide overview and update on vendor deliverables.
  • Assist in the leadership of the program team, as directed by Chief Medical Officer, Chief Operating Officer and Head of Clinical Operations to facilitate their ability to lead extended cross-functional project team. This includes the maintenance of timelines in MS Project, creation of PowerPoint presentations and issues escalation.
  • Other responsibilities related with employee's specialization & competences delegated by Supervisor.
YOUR BACKGROUND
  • Minimum 10 years of experience in the pharmaceutical industry or CRO including at least 2 years global clinical project management experience.
  • Current GCP training (must have)
  • Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in early phases of development in oncology/hematology.
  • Extensive knowledge of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
  • Operational expertise in risk management and contingency planning.
  • Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, with strong conflict management skills.
  • Effective problem solving and conflict resolution skills with a solutions-oriented mindset.
  • Strong influencing and stakeholder management skills.
  • Ability to create a trusting partnership based on feedback culture.
  • Excellent communication skills
  • Strong organizational skills.
  • Performance management skills.
  • Good judgment and decision making skills.
  • Fluent English
  • Strong Time management skills.
  • Attention to details
  • Ability to motivate and integrate teams.
YOUR BENEFIT PACKAGE
  • Work in one of the most innovative companies in the region with a proven track record and high perspective of growth
  • Collaborative and supportive work culture
  • Training program enabling scientific development: Ryvu Academy, scientific lectures, participation in conferences
  • Package of benefits: Luxmed, Multisport and many others
  • Onsite support for foreigners and help with relocation
  • Mindgram - wellbeing platform
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