Clinical Project Manager

Are you a Clinical Research professional with a passion for drug development? Then come and join us!
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What we offer

Joining our consulting team in Belgium 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

Keyrus Life Science is looking for a Clinical Project Manager to join our consulting team for a client project based in Belgium

1)  You will be responsible for assigned study/project management within the unit including study scheduling, protocol planning (start up activity) and will be the primary contact for the project teams responsible for the compound/project - from the time the study/project document is drafted until the data base/project is locked. 

  • Serve as primary liaison/point of contact for the assigned Core Project Teams and the Clinical Research Unit (CRU).
  • Create and ensure adherence to study timelines.
  • Supervise initiation and monitoring of all study activities.
  • Primary point of contact for assigned study decisions related to the protocol, data collection and volunteer activities.
  • Partner with different CRU departments for the planning and execution of study.
  • Maintain accuracy, accessibility and confidentiality of all volunteer records and reports.
  • Monitor and summarize clinical data.
  • Evaluate and may identify new equipment/technologies/vendors for improving study execution.
  • Lead the data management activities for assigned protocols.
  • Initiate Inform Consent Document for Ethics Comitee submission.

2)  You will also be responsible for ensuring clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines. Responsible for volunteer safety and accurate interpretation and execution of research protocols including multiple study activities.

  • Contribute to the clinical study components with respect to time, operational feasibility, and study-level CRU resources required to deliver individual studies against the development plan (part of the study budget).
  • Assess impact of technologies required to deliver clinical trials and incorporates the development of these technologies into the clinical studies to ensure qualitative conduct and data collection suitable for purpose.
  • Provide support for Methodology/Mechanistic studies as appropriate.
  • Partner with Core Project Teams to provide study schedule and budget information to enable project management.
  • Identify performance/quality issues to develop appropriate remediation plan.
  • Identify and escalate system or process issues hindering delivery.
  • Oversee the creation and detailing of study activity/source documents.
  • Supervise/Monitor the initiation and quality control of all study related activities for assigned protocols.

3)  Finally, you will also initiate and manage all operational study activities:

  • Provide critical operational and feasibility input to study design.
  • Contribute to the protocol development.
  • Align and influence study level operational strategies across programs and partner lines.
  • Provide critical assessment of strategic partner and vendor proposals to ensure study success.
  • Ensure appropriate level of oversight is maintained utilizing escalation plans and providing resolution to issues at the study level.
  • Forecast site level clinical trial budget.
  • Work proactively with other functions and strategic partners for timely delivery of quality data.
  • Oversee the overall execution of clinical studies.
  • Participate in study meeting with relevant partners for operational alignment.
  • Communicate opportunities and risks to the Core Project Teams for integration in risk management plans.
  • Effectively coordinates all functional areas involved in clinical trials to solve problems and assure progress and timely completion of study goals.
  • Anticipate potential problems within a clinical trial and creates contingency plans accordingly.
  • Mentor and coach other clinic staff as needed.
  • Initiate general staff training activities.
  • Lead data management: Manages all queries specific to subject data collection & Supports in eHR setup activities.
  • May represent the unit on Local or Global initiatives (Global SOP’s, process improvement teams, other activities as they present themselves) as they are the subject matter experts in the Unit.
  • May Lead CRU teams in accomplishing business needs and resolving issues.
  • May represent the CRU as a subject matter expert for internal/external resource (provide support to external center, etc.).
  • Participate in study and staff scheduling for assigned protocols, as appropriate.
  • Oversee creation and detailing of study activity documents for staff & volunteer use.

 

Profile

  • Minimum of Bachelor or Bachelor of Science in a biomedical discipline or equivalent education/training is required.
  • At least 5 years relevant experience in clinical research and drug development with clinical operations experience (Clinical Study Management & monitoring, data management, regulatory processes, budget management, etc.). Preferably with first experience in early drug development (Phase I and IIa).
  • Substantial clinical operations and pharmaceutical industry experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues.
  • Experience in Project Management and leadership of matrix teams is essential.
  • Fluent in speaking and reading English. Preferably, your second language would be French or Dutch (for CRU BR).
  • Soft skills: open to change, learning organization, flexibility and resilience, problem solving, forward thinking, challenge the status quo.
  • Leadership skills: influencing, collaborative, supportive, networking and alliance building, personal leadership, team work, communication, negotiation, decisive and assertive, able to deal with ambiguity.

 

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 skilfully, 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

    Hybrid remote

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

Belgium

Belgium
6211 BE 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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