Transparency Operations Lead - Monheim, Deutschland - UCB S.A.

UCB S.A.
UCB S.A.
Geprüftes Unternehmen
Monheim, Deutschland

vor 2 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

Make your mark for patients


We are looking for a
Transparency Operations Lead to join us in our
Patient Safety & Medical Management team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK) or Raleigh (US) offices.


At the crossroads of science and operations, the Transparency Operations Lead position combines policy oversight, scientific data handling, cross-functional project work, and communication to provide timely and compliant deliverables.

The Transparency Operations Lead connects with global stakeholders across the company and beyond to drive a culture of transparency at UCB.

In addition, this role is responsible for monitoring the global landscape to identify trends and opportunities that will allow UCB to remain a leader in data transparency and disclosure.

As a
Transparency Operations Lead you will have the following responsibilities:

  • Identify studies required for plain language summaries of protocols and results
  • Ensure staff involved in development of plain language summaries of protocols and results are aware of their responsibilities and timelines
  • Coordinate review and approval by relevant stakeholders of plain language summary of protocols and results documents assisting with adjudication of comments, as needed
  • Oversee selected vendors assigned to data transparency and disclosure deliverables for UCB including:
  • serving as point of contact for operational delivery and resolution of issue escalations
- providing oversight of deliverables in accordance with established performance metrics and compliance with regulations and UCB policies and procedures including relevant quality reviews
- being responsible for vendor budgets and review of invoices

  • Support the Disclosure Lead with activities related to protocol registration, maintenance, and results reporting
  • Support development of processes and guidance related to UCB's data disclosure and transparency policy in conjunction with Transparency Operations Lead, Disclosure Lead, and other key stakeholders
  • Support development of educational materials and provide training on UCB's data disclosure and transparency policy and related standard operating procedures and associated instructions
Interested? For this position you'll need the following
education,
experience and
skills:

  • Bachelor's degree
  • Experience in data transparency and disclosure activities required with experience in clinical development including trial management, biostatistics, medical writing, or regulatory, a plus
  • Knowledge of data transparency to include:
  • plain language summaries of protocols and results, data sharing, redaction, and anonymization activities
- awareness of data sharing platforms and their use
- awareness of various transparency vendors
- basic knowledge of statistical methodology

  • Awareness of , European Clinical Trial Information System and other local clinical trial registries and awareness of disclosure systems and their use
  • Strong computer skills proficiency in MS Office; comfortable with using data/document management systems (e.g., CTMS), XML
  • Basic knowledge of regulatory requirements for conducting clinical trials, including FDA/EMA regulations, ICH/GCP regulatory environment
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you


About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.


Why work for us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients.

We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work.

We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees or our planet.

Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.


Learn more about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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