Yacht Life Sciences has a vacancy for a Clinical Registry Specialist at our client, a global biotechnological company.
As a Clinical Registry Specialist you will be responsible for developing processes and tools to support streamlined International disclosure for assigned countries. You act as a Subject Matter Expert for supporting all of the operational aspects of the Clinical Registry workflow in support of study registration and result disclosures to public websites for pharmaceutical companies. You coordinate and maintain oversight on protocol registration and/or results disclosure in assigned countries. Next, you ensure the quality of global operations and the data integrity of the Clinical Registry and associated external web sites by facilitating problem resolution for new users and customers. Dependent on the candidate, the position may be expanded to include supporting results disclosure in the EudraCT database. The exact portfolio of countries and registries will be determined by the CR management.
- Understand the global clinical registry landscape and customer needs for protocol and/or results disclosure.
- Keep abreast of and document changing regulatory disclosure requirements for the assigned countries: Perform impact assessment and document required changes to the Clinical Registry Repository Content.
- Partner with relevant Local Operating Company personnel to:
- Maintain up to date disclosure requirements for the country
- Obtain a correct interpretation of the local disclosure requirements
- Create a country specific disclosure agreement if appropriate, including processes to support adherence to the local registry requirements
- Ensure timely availability of approved registry data to ensure on time, accurate and consistent clinical data disclosure
- Maintain up to date registration and disclosure intelligence (i.e. regulatory intelligence, registry intelligence,…) in the International Clinical Registry Repository
- Assist with disclosure assessments for internal and external conducted studies
- Tracks disclosure and other requests for international clinical registries
- Produce metrics showing compliance for disclosure activities
- Training of global customers and cross‐functional internal training as related to Clinical Registry
- Participate in Clinical Registry Team projects for enhancement of processes and technologies in use
- Analyse registration and disclosure data as required
- Collect and follow up data quality feedback from NIH and other registry related organizations. Ensure timely resolution of raised feedback
- Provides back-up and continuity of registry operations during US business hours. This includes follow up of discussions with Clinical Development Team, Operation, Regulatory or others as appropriate, posting of information to public websites in US or EU.
- Works with the operations team for selected tasks
- Monthly assessment to determine trials in scope
- Request EMA trial access in EudraCT system
- Request XML files for Programming
- Submit results to EudraCT
- Keep EudraCT tracker updated
- Liaison with stakeholders as needed during disclosure process
Decision-making and problem-solving:
The scope of the role is across various functions, segments and specifically BRQC, and requires collaboration, alignment, and influencing.
- Excellent problem solving and decision making skills
- Strong planning, organizational, and project management skills
- Ability to lead and support project teams and responsible for balance of priorities
- Willing to take the lead in working complex technology/information solutions
- Strong change management and stakeholders management skills