Global Project Manager
il y a 3 semaines
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Global Project Manager - EU - Immunology/OncologySector: Health and Medical
Role: Manager
Contract Type: Permanent
Hours: Full Time
New opportunity for an experienced Senior Global Clinical Project Manager to join our growing FSP program sponsor dedicated. This is a permanent and home-based role.
This role is remote and can be based in EU wide apart from Switzerland.
The role
- Accountable for the delivery and quality of site level activities in Phase I-IIIb Clinical Development studies; act as link between Clinical Site Leads, Global functions & CRO counterparts - single point of contact for site management & operational topics/escalations; support information channelling and issue resolution for the study.
- Provide leadership, strategic direction and operational oversight for Clinical Site Lead (CSL) activities across assigned study(ies) in response to quality and performance oversight measures and trends.
- Serve as the operational delivery expert for the study(ies) and promote data-driven, realistic planning at the site and study level. Drive delivery-focused accountability and ownership amongst key external (CRO/vendor partners) and internal partners as appropriate.
- Facilitate identification and implementation of operational excellence strategies within studies - leveraging expertise within Global Development Operations (GDO) and other partner functions.
- Ensure timely and appropriate escalation of trends, issues and risks within the Clinical Operations Team/Clinical Trial Team/CRO/Vendor Team, department Leadership Team and/or Senior Management as appropriate.
- Promote solution-oriented thinking and issue resolution at the country and study team level. Provide an escalation pathway to ensure study-specific major observations from CSLs are relayed to and followed up by the appropriate internal and/or external business partners.
- Support product and study-specific onboarding for new CDPC team members and contribute to enhancing their site/study management capabilities/skills.
You are a solution-oriented individual, with strong interpersonal and presentation skills with the following background:
- Requires graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalent.
- Clinical operations experience - ideally across Phases (I-IIIb).
- Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g., ICH GCP and applicable regional/local regulations).
- Oncology and/or Neurology and/or Immunology TA experience desired.
- Substantial (10+ years) professional and project management experience in clinical research in a CRO, pharma or biotech company including site management/oversight, clinical study planning and conduct.
- Adaptability / Flexibility, Critical Thinking, Strong Communication Skills, Analytical Skills, Business Partnering, Clinical Trials Knowledge, Influencing Skills, Strategic Thinking, Therapeutic Area Knowledge.
- Ability to work independently on assigned tasks or projects.
- Aptitude to interpret outputs from analytical tools to enhance and improve study execution.
- Ability to assess risk, solve problems and take decisions.
- Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way.
- Demonstrated good interpersonal skills.
- Good cultural awareness.
- Comfortable working in a fast-paced environment where speed is paramount.
- Fluency in English (oral and written) plus local language.
- Position may require domestic/international travel up to 20% of time.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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