Clinical Trial Disclosure II

Job Description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs. 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. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***