Auftragsdetails

Detailed Description

Essential Functions:

• Performs/coordinates all activities for the registration, maintenance, and results postings, including document redaction for clinical trials across global registries including Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable.
• Ensures development of high-quality registration, maintenance, and results deliverables that are compliant with all applicable policies, procedures, and regulations.
• Performs quality control review of registry deliverables, ensuring accuracy against all relevant source documents.
• Works closely with the internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Client’s disclosure obligations.
• Works with the internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner.
• Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking.
• Sets expectations where necessary and reports on project statuses to senior management. Makes decisions regarding issue resolution.
• Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues.
• Develops strong, lasting relationships with client teams that encourage organic new business growth.
• Other duties as assigned.

Necessary Skills and Abilities:

• Strong written and verbal communication skills.
• Self-motivated and able to work independently.
• Exceptional time management skills.
• 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.
• A proven team player who can focus on and drive goal completion.
• Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency.

Educational Requirements:

• Minimum of bachelor’s degree in related field (scientific field preferred).

Experience Requirements:

• Minimum of 3+ years of direct experience in disclosures and/or data transparency.
• CRO or Outsourcing experience preferred.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.