Clinical Trial Registry & Results Disclosure Compliance Lead (m/f) UCB S.A. Monheim February 2018 . Anyone want to get into a pleasant working environment as well as challenging. In a work place that is friendly as well as open with the occasions, we ensure that each one gets an equal possibility to continue to develop their selves and their careers having UCB S.A.. UCB S.A. has a friendly working environment, friendship, and mutual help. The leaders inside the UCB S.A. is also actively guide, support, and enjoy every positive thought given its employees. We believe that every worker requires a balanced living. Now this UCB S.A. is hiring Clinical Trial Registry & Results Disclosure Compliance Lead (m/f) in Monheim, to get quality human resources. The following is the whole information if you are considering a career with UCB S.A. Monheim.
Clinical Trial Registry & Results Disclosure Compliance Lead (m/f) February 2018
UCB S.A. Monheim
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. Starting ideally on the 1st of April 2018 we search for a Clinical Trial Registry & Results Disclosure Compliance Lead to be based in Monheim, Germany. This role is a fixed term position for 18 months (parental leave cover). Scope of the role: At the crossroads of science and operations, the Clinical Trial Registry & Results Disclosure (CTRRD) Compliance Lead role combines scientific data handling, cross-functional project management and communication to deliver timely and compliant disclosure of Company-sponsored clinical trial data. The CTRRD Compliance Lead is responsible for executing disclosure activities for UCB-sponsored trials, including protocol registration and results disclosure, ensuring compliance with legal requirements and in line with Company transparency commitments, and providing high-quality disclosure deliverables. An assigned administrator for centralized data entry into our Clinical Trial Registry system, the CTRRD Compliance Lead ensures posting of trial information onto ClinicialTrials.gov, EudraCT and specific local registries. A master at proactive planning and communication with interfacing functions, and with a solid scientific background, the CTRRD Compliance Lead enables proper and timely disclosure of trial information in full understanding of medical context. The CTRRD Compliance Lead also contributes to the maintenance and continuous improvement of processes, standards and systems that support clinical trial disclosure. As Subject Matter Expert for trial disclosure, the CTRRD Compliance Lead conducts internal stakeholder trainings on disclosure-related matters, and actively participates in cross-functional initiatives pertaining to trial transparency. Your responsibilities in this role include:
Managing trial protocol registrations and coordinating results reporting on ClinicalTrials.gov & EudraCT within mandated timeframes; completing initial data entry based on protocol working in close collaboration with study teams; managing day-to-day collaboration with vendor(s) as required;
Coordinating review and approval of study Disclosure Plan & Results Master Document by relevant stakeholders;
Extracting information from clinical trial management system databases at regular intervals and updating study records on registries as required; updating study records with links to product labels & citations of publications;
Serving as Initial Point of Contact with the National Library of Medicine QA Group to resolve questions prior to public release of data on ClinicalTrials.gov;
Updating project tracking systems, maintaining complete, accurate & consistent records reflecting entry of data onto registries; archiving related documentation;
Developing and maintaining efficient working relationships with contributing departments (e.g., Clinical Project Management, Statistics, Medical Writing, Regulatory Affairs, Safety)
Supporting local teams/vendors responsible for data entry into local registries to ensure consistency of trial information disclosed across national registries;
Preparing presentations / providing training to internal stakeholders on clinical trial disclosure-related guidelines & processes;
Providing input into transparency-related projects/initiatives
Your qualifications and experience level for this role:
Academic degree in natural sciences
; 1 year relevant industry experience in/with clinical development, preferably trial &/or data management &/or biostatistics, or Regulatory Affairs) Experience with – or capability to identify, analyze & apply – relevant regulations & guidelines applicable to clinical research Basic knowledge of regulatory requirements for conducting clinical trials, including FDA/EMA regulations, ICH/GCP regulatory environment Data-driven; attention to detail
Excellent communication/interpersonal skills; ability to work effectively with multidisciplinary & international teams
Strong project planning, time management & organizational skills; ability to independently manage multiple responsibilities in an environment of changing priorities without close supervision
Excellent English and German verbal & written communication
Strong computer skills – proficiency in MS Office; comfortable with using data/document management systems, XML
Ability to deliver presentations & training
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 4.2 billion in 2016. Do you want to find out more about us? Then visit our website: www.ucb.com
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