Clinical Trial Job at ProPharma – Apply Now!

Essential Functions:

• Indepentendly performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable).
• Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations.
• Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents.
• Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Client’s disclosure obligations.
• Works with 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 manager.  Escalates issues to manager in a timely manner.
• 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.
• Thinks proactively, takes initiative, and willingly takes on new challenges.
• Ability to identify areas of concern or inefficiency
• Works independently with good time management skills and contacts management team proactively when additional support and resources are needed.
• Works effectively in a collaborative team environment.
• Demonstrates a growth mindset and positive outlook in all work activities.
• Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Educational Requirements:

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

Experience Requirements:

• Minimum of 2+ years of direct experience in disclosures and/or data transparency.
• CRO or Outsourcing experience preferred.