Global Clinical Project Manager

You are a Senior Clinical Project Manager and you want to have a more global approach? Then jump in!
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What we offer

Get the opportunity to lead the internal Clinical Study Team on studies of all types from First in Human to Phase IV, and to manage the interface between the company , Phase 1 Units, CROs and other vendors.

Joining our consulting team means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Job Description

  • Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective coordination and communication within and across the company internal and CRO/Phase 1 Unit teams.
  • At the study kick-off meeting, articulate study scope, goals, and expectations of the company to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning.
  • Create, or contribute, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making. Such as for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, and final data reporting for Results Interpretation Meetings and final CSR.
  • Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments.
  • Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.
  • Become familiar with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations.
  • Understand, manage, track and ensure accuracy of study budgets in the company’s systems, including the forecast and accrual information.
  • For assigned studies, work closely with the respective Program Delivery Leads, and other team members and stakeholders as required, to serve as the key internal clinical operations contact whilst keeping the PDL updated on all study issues.
  • Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings (RIMs).
  • Visit investigational sites and Phase 1 Units to build and maintain relationships as well as to understand opportunities and challenges to study conduct, including enrollment, when needed for assigned clinical studies.
  • Travel including overnight stays- possibly global - required.

Profile

  • At least 3 years’ relevant experience in clinical development including team leadership.
  • Bachelor's degree in the pharmaceutical field.
  • Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies (First in Human to multicenter clinical studies) from study start-up to study report completion.
  • Motivation, mentoring and integration of individuals on multi-functional international teams.
  • Delivery of scientific/medical presentations and training to both large and small audiences.
  • Excellent verbal and written communication in English.
  • Proficiency in the Microsoft office suite.
  •  Good interpersonal skills.
  • Excellent time management and organizational skills.
  • Negotiation skills
  • Scientific and technical knowledge: GCP and regulatory environment, medical knowledge and research expertise, basic principles of data management and statistics.
  • Managing multiple concurrent responsibilities in an environment of changing priorities without close supervision

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

Additional information

  • Remote status

    Flexible remote

We usually respond within a week

Or, know someone who would be a perfect fit? Let them know!

Brussels

1000 Brussels Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

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