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Clinical Trial Transparency And DisclosureSpecialist
2 months ago
About thejob
For the past 20 yearsProPharma has improved the health and wellness of patients byproviding advice and expertise that empowers biotech med device andpharmaceutical organizations of all sizes to confidently advancescientific breakthroughs and introduce new therapies. As the worldslargest RCO (Research Consulting Organization) ProPharma partnerswith its clients through an advisebuildoperate model across thecomplete product lifecycle. With deep domain expertise inregulatory sciences clinical research solutions quality compliancepharmacovigilance medical information and RD technology ProPharmaoffers an endtoend suite of fully customizable consulting solutionsthat derisk and accelerate our partners most highprofile drug anddevice programs.
The Clinical Trials DisclosureSpecialist I position is responsible for the overall coordinationand development of multiple disclosures deliverables including butnot limited to compliant registry authoring and maintenance ofinformation on public registries document redaction and/or plainlanguage authoring ensuring adherence to relevant industryguidelines and client styles and formatting in accordance with allagreed upon timelines.
EssentialFunctions
- Performs/coordinates all activities for registration maintenanceand results postings including document redaction for clinicaltrials across global public registries (i.e. Clinicaltrials.govEudraCT and other countryspecific registries asapplicable).
- Ensures development ofhighquality registry redaction and plain language documentdeliverables that are compliant with all applicable policiesprocedures and regulations.
- Performs qualitycontrol review of registry and/or plain language documentdeliverables ensuring accuracy against all relevant sourcedocuments.
- Works closely with internal Clientteam(s) to ensure understanding of applicable roles andresponsibilities related to Clients disclosureobligations.
- Works with internal Clientteam(s) to ensure the source information is provided for disclosureactivities in a timely manner.
- Maintainsaccurate and uptodate records of individual study activities fortimeline integrity compliance and relevant metricstracking.
- Sets expectations where necessaryand reports on project statuses to senior management. Escalatesissues to senior management in a timelymanner.
- Provides frequent and purposefulcommunication ensuring all stakeholders are kept informed ofprogress and updates as needed in real time. Maintains constructiveand positive interactions with colleagues.
- Develops strong lasting relationships with client teams thatencourage organic new business growth.
- Otherduties as assigned.
Necessary Skills AndAbilities
- Strongwritten and verbal communication skills.
- Selfmotivated and able to work independently.
- Exceptional time management skills.
- Ability todrive projects with conflicting priorities in a matrix teamenvironment working with individuals from a variety of departmentsand in a range of countries.
- A proven teamplayer who can focus on and drive goalcompletion.
- Ability to understand and applyinternational regulations and Client guidelines and requirementsrelated to clinical trial transparency.
EducationalRequirements
Bachelors degree orhigher preferably in medical or scientific discipline.
ExperienceRequirements
02 years of directexperience in disclosures and/or data transparency.
CRO or Outsourcing experience preferred.
We celebrate our differences and strive to create aworkplace where each person can be their authentic self. We arecommitted to diversity equity and inclusion. Employees areencouraged to unleash their innovative collaborative andentrepreneurial spirits. With a holistic approach as an EqualOpportunity Employer we provide a safe space where all employeesfeel empowered tosucceed.
Lifelancer ( )is a talenthiring platform in Life Sciences Pharma and IT. Theplatform connects talent with opportunities in pharma biotechhealth sciences healthtech data science and ITdomains.
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