Auftragsdetails

Detailed Description

The clinical trials disclosure associates should be able to oversee the end-to-end operations for clinical trials registration maintenance and results posting on clinicaltrials.gov, EudraCT, JapicCTI, jRCT and similar databases worldwide (disclosure operations process). To ensure compliance, the clinical trial disclosure associates will work with study teams to perform activities in accordance with the client policy for clinical trial data transparency and the clinical trial disclosure regulations

Specific duties include but will not be limited to the following:

• Performing/coordinating all activities for the registration, maintenance, and results postings for clinical trials across global registries including Clinicaltrials.gov, EudraCT, JapicCTI, jRCT, and other country-specific registries as applicable.
• Ensuring development of high-quality registration, maintenance, and results deliverables that are compliant with all applicable policies, procedures, and regulations.
• Working closely with the internal Client team to ensure they understand their roles and responsibilities related to Client’s disclosure obligations
• Working with the internal Client team to ensure the source information is provided for disclosure activities in a timely manner
• Project management and tracking: maintain accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking.
• Completion of a disclosure skills assessment is a screening requirement as part of the recruiting process.

Background Required

• Masters or PhD in pharmacy or life sciences OR MBBS/BDS/BPT with relevant experience
• 3+ years of experience with study registration and results disclosure on clinicaltrials.gov or other country databases.
• Experience of supporting and managing tasks / projects, by establishing strong relationships and coordinating those resources (internal and external) to achieve deliverables in compliance with process and / or contract.
• Strong verbal and written communication skills
• Superior attention to detail
• Project/stakeholder management: ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries
• Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency.
• Flexible and proactive.