Clinical Trial Transparency And Disclosure Specialist
2 months ago
About the job
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. As the worlds largest RCO (Research Consulting Organization) ProPharma partners with its clients through an advisebuildoperate model across the complete product lifecycle. With deep domain expertise in regulatory sciences clinical research solutions quality compliance pharmacovigilance medical information and RD technology ProPharma offers an endtoend suite of fully customizable consulting solutions that derisk and accelerate our partners most highprofile drug and device programs.
The Clinical Trials Disclosure Specialist I position is responsible for the overall coordination and development of multiple disclosures deliverables including but not limited to compliant registry authoring and maintenance of information on public registries document redaction and/or plain language authoring ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines.
Essential Functions
- 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 countryspecific registries as applicable).
- Ensures development of highquality registry redaction and plain language document deliverables that are compliant with all applicable policies procedures and regulations.
- Performs 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 Clients 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 uptodate 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. Escalates issues to senior management 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.
- Selfmotivated 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
Bachelors degree or higher preferably in medical or scientific discipline.
Experience Requirements
02 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.
Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech data science and IT domains.
Please use the below Lifelancer link for job application and quicker response.
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Remote Work :
No
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Hyderabad, Telangana, India Lifelancer Full timeAbout UsLifelancer is a talent hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.We are seeking a highly skilled Clinical Trial Transparency and Disclosure Specialist to join our team. As a Clinical Trial Transparency and Disclosure Specialist,...
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Hyderabad, Telangana, India Lifelancer Full timeAbout LifelancerLifelancer is a talent hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.The Clinical Trials Disclosure Specialist position is responsible for the overall coordination and development of multiple disclosures deliverables,...
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hyderabad, India Lifelancer Full timeAbout the job 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. As the worlds largest RCO (Research Consulting Organization) ProPharma...
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hyderabad, India Lifelancer Full timeAbout the job 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. As the worlds largest RCO (Research Consulting Organization) ProPharma...
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