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Senior Manager Clinical Standards & Programming - Seqirus - 363BR
Amsterdam, Amsterdam, Netherlands
Are you looking for a rewarding career in a market-leading and innovative company?Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create what is now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Our site in Liverpool is a Centre of Excellence for egg-based influenza vaccine manufacturing – it is one of the biggest biotechnology sites in Europe and the only injectable influenza vaccine manufacturer in the UK. It also produces the only licensed adjuvanted seasonal influenza vaccine. Currently for our Biostatistics and Programming department we are looking for: Senior Manager Clinical Standards & ProgrammingThe Senior Manager Clinical Standards & Programming is a key leadership position responsible for providing strategic leadership to and managerial oversight of the group of Global Standards & Programming Managers. The incumbent will provide strategic direction for the development and implementation of consistent clinical standards ensuring quality, consistency, continuous availability of data across all clinical programs and alignment with regulatory requirements for electronic submission. In his role he will also actively support the implementation of Clinical Standards. The position can be based in our office in Amsterdam, Netherlands or Cambridge, MA, USA. Accountabilities:
Profile: Education:Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experience. Other degrees and certifications considered if commensurate with related data management/statistical programming experience.Experience:Solid experience in either clinical data management and/or statistical programming, within the CRO/pharmaceutical environment.A comprehensive understanding of data management and/or statistical programming processes and standards as well as current regulatory requirements for data management and data standards for submission.Advanced knowledge in statistical programming using SAS.Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).Knowledge of at least one widely used CDMS and preferably experience of working with an EDC platform (Medidata Rave preferred).Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines. Experience in working in cross-functional, multicultural and international clinical trial teams.Other competencies:Excellent communication and analytical skills.Strong interpersonal skills and track record of staff management and effective leadership. Excellent organisational skills and ability to prioritise individual and departmental workloads; strong strategic planning and organizational skills.Ability to work successfully in a matrix organizational structure.Strong negotiation skills and able to identify and engage internal and external expertise as needed.Proven networking skills and ability to share knowledge and experience amongst colleagues.Fluent in English, oral and written.
- Drive the development of Clinical Standards such as: eCRFs, edit checks, statistical programming (TFLs), clinical data archiving, etc., as part of the BDPM standards initiative. Oversee the generation of an eCRF global library, including an appropriate documentation.
- Lead and support projects to implement the agreed Clinical Standards within CR&D and implements a system to manage and document them.
- Establish the framework to ensure quality and accuracy – thus submission readiness – of clinical data as required by authorities (i.e. CDISC, CDASH, SDTM, ADaM, define.xml).
- Oversee the development and maintenance of department and cross functional Standard Operating Procedures and related QMS documents.
- Drive the development of Data Visualization tools providing information about data quality, study metrics, etc.
- Develop and conduct presentations and workshops to inform and educate stakeholders within BDPM and CR&D on Clinical Standards & Programming related topics. Develop networks with external parties (key experts, contract research organizations) as pertains to Clinical Standards.
- Provide guidance on management of data storage and retrieval processes in a format that allows pooled analyses and exploration of legacy data. Collaborate with Global Biostatistics in the implementation of a Clinical Data Repository.
- Ensure provision of SAS programming to provide ready to analyse datasets in support of Biostatistics with clinical data analyses as required, including but not limited to quality oversight and consistency of clinical data, support of ongoing clinical trial evaluation, analyses for publications and regulatory submissions, health economic evaluations, explorative data analyses for planning of new trials.
- Provide guidance and oversight to CROs. Lead a team of Global Standards & Programming Managers within Global Clinical Data Management & Programming.
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