Senior Clinical Project Manager 1
Date: Aug 23, 2019
Location: Braine L'alleud, Walloon Brabant, BE
Our challenge. Your impact.
We aspire to be the patient-preferred global biopharmaceutical leader transforming the lives of people with severe diseases and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.
To strengthen our Global Clinical Sciences & Operations (GCSO) team, based in our UCB Offices in Germany, Belgium or UK we are looking to recruit a Senior Clinical Project Manager.
Your responsibilities in this role include:
* Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the UCB internal and CRO teams.
* 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.
* Create or contribute 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.
* Ensure that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensure that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the CRO.
* Supervise 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.
* 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.
* 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.
* Work closely with the Program Delivery Lead, other team members and stakeholders as required and serve as the internal key contact for their assigned studies.
* Collaborate 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.
* Support Data cleaning and data evaluation meetings and Results and interpretation meetings (RIMs)
* Support conduct of DMC/safety review meetings
* Ensure 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.
* Provide study specific training for internal (i.e. UCB) and external (i.e. CRO, vendors, investigators) team members.
* Identify 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.
Your qualifications and experience level for this role:
* 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 3,3b, 4 studies (First in Human to multicenter 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
Have we made you curious?
Then we look forward to receiving your online application (please only use our online application tool) for this position stating your earliest availability or actual notice period as well as salary expectations. We thank you for your interest in UCB and look forward to get in touch with you! UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7700 people in approximately 40 countries, we generated revenue of EUR 4.6 billion in 2018.
Do you want to find out more about us then visit our website: www.ucb.com
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