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Let's push the boundaries together and make the most of your talents!

Senior Clinical Project Manager

Location: 

Monheim, Mettmann, Germany

Job Function:  Clinical Development
Job ID:  69149

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

To strengthen our Global Clinical Sciences and Operations department, based either in Monheim (Germany), Brussels (Belgium), Slough (UK), or Raleigh (US), we are looking for a talented individual to fill the position of Senior Clinical Program Manager.

 

As a Senior Clinical Project Manager, you will be tasked with leading one or more multi-functional, Clinical Study Team/Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the UCB internal and CRO teams to successfully manage the conduct of global clinical studies within defined timelines and study budget.

 

You will contribute by:

  • Helping articulate study scope, goals and expectations of UCB to the CRO at kick-off and ensure they are informed about any relevant sponsor information that may impact the management of the trial throughout the conduct of the trial. 
  • Creating or contributing to detailed planning of the study, timelines, define critical path to enable seamless access to data, early read out of bioanalytical and safety data to enable data review meetings and early decision making. 
  • Ensuring that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensuring that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the CRO.
  • Supervising study conduct by regularly reviewing CRO performance through the review of KPIs, metrics and deliverables, with a focus on critical activities that might delay the project, jeopardize quality, and/or impact budget.
  • Ensuring 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. 
  • Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence. Findings, including mitigation plans, to be discussed with the CRO and communicated to all appropriate internal and external stakeholders.
  • Working closely with the Program Delivery Lead, other team members and stakeholders as required and serve as the internal key contact for their assigned studies. 
  • Collaborating with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols and protocol amendments and study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope.
  • Supporting Data cleaning and data evaluation meetings and Results and interpretation meetings (RIMs)
  • Supporting conduct of DMC/safety review meetings 
  • Ensuring quality and adherence to the relevant UCB SOPs, GCP, regulatory guidelines and working practices. Support any audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.
  • Providing study specific training for internal (i.e. UCB) and external (i.e. CRO, vendors, investigators) team members.
  • Identifying issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs.

Interested? For this position you’ll need the following education, experience and skills:

  • Relevant Bachelor’s degree needed with an advanced degree of PhD preferred
  • Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies (First in Human to multi-center clinical studies) from study start-up to study report completion.
  • Substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end.
  • Motivation, mentoring and integration of individuals on multi-functional international teams
  • Delivery of scientific/medical presentations and training to both large and small audiences
  • Good interpersonal skills and excellent time management and organizational skills
  • Proactive approach, drive and follow through
  • Scientific and technical knowledge:
    • GCP and regulatory environment
    • Medical knowledge and research expertise
    • Basic principles of data management and statistics
  • Reconciliation of conflicting priorities

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

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