
Clinical Trials Registry Coordinator
5 days ago
Job Title: Clinical Trials Registry Coordinator
\Are you a detail-oriented professional with excellent communication skills and experience in clinical trials? Do you have a passion for regulatory compliance and a desire to make a meaningful impact in the healthcare industry?
\We are seeking a skilled Clinical Trials Registry Coordinator to join our team. In this role, you will be responsible for supporting the development and implementation of clinical trial registry systems and processes, ensuring global transparency regulations and requirements are described and implemented.
\You will collaborate with cross-functional teams across multiple geographies and phases of drug development to ensure accurate and timely posting of clinical trial protocol information and study results. This is an exciting opportunity to work in a dynamic environment and contribute to the success of our organization.
\Responsibilities:
\- \
- Clinical Trial Registry and Results Planning, Development, Finalization, and Document Management\
- Contribute to the development, maintenance, and implementation of policies and/or procedures on clinical trial registry and clinical trial results database processes and work flows. Identify opportunities for process improvements.\
- Identify studies required for registry and results postings. Ensure that responsible functions are aware of timelines and deadlines.\
- Collaborate cross-functionally with applicable team members and departments (e.g., biostats, medical, clinical trial management) to obtain data required for completion of registry and results entries.\
- Manage access rights to applicable systems as needed.\
- Serves as subject matter expert on CTR database requirements.\
- Develop and provide education and training as required to internal groups.\
- Define and monitor applicable metrics to support overall compliance.\
- Maintains and enhances knowledge of CTR regulations and guidelines.\
- Exhibits flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc.\
- Project Management / Influence / Knowledge Sharing\
- Supports the systems and process for CTR and works with other team members to ensure consistent practices are monitored and employed globally.\
- Provides input to deliver innovative solutions, preventing re-occurrence of issues.\
- Escalates issues in a timely and appropriate manner.\
- Ensures the evaluation (monitoring) of the CTR processes and communicating changes to the processes to the business. Shares key learning to drive simplification and replicate best practices.\
- Bachelor's degree in scientific, health, communications, or technology-related field or equivalent experience\
- Demonstrated high-level end-user computer skills (MS office applications: Word, Excel, PowerPoint, etc.)\
- Demonstrated mastery of English language skills written and spoken\
- Experience with CTR processes and databases\
- Experience in biostatistics, medical/regulatory writing\
- Verbal reasoning, attention to detail, critical thinking, and analytical ability\
- Demonstrated project management and time management skills\
- Ability to be flexible in varying environments and with multiple customer groups\
- Able to work independently as well as part of a team: able to take initiative and responsibility, following through and completing assigned tasks\
- Able to deal with ambiguity and to plan, prioritize, and manage conflicting priorities\
- Strong interpersonal and negotiation skills - Ability to manage upwards\
- Strong medical research background with demonstrated breadth and depth of knowledge of medical research processes throughout all phases of development\
- Developed networks and proven ability to influence cross-functionally at all levels\
- Ability to influence/lead others\
- Ability to work well across cultures and time zones\
About Us:
\We are a leading organization in the pharmaceutical and life sciences industry, committed to delivering innovative solutions and exceptional service to our customers.
\What We Offer:
\- \
- Competitive salary and benefits package\
- Opportunities for career growth and professional development\
- A dynamic and supportive work environment\
- Recognition and rewards for outstanding performance\
- A commitment to diversity, equity, and inclusion\
- A comprehensive employee assistance program\
How to Apply:
\If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and cover letter, to [insert contact information].
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