Manager - Clinical Trial Transparency

3+ years

Not Disclosed

Bangalore

10 Jan. 22, 2025

Job Description

Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager - Clinical Trial Transparency

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locations

India, Bangalore

time type

Full time

posted on

Posted 2 Days Ago

time left to apply

End Date: February 20, 2025 (28 days left to apply)

job requisition id

JR127460

Manager - Clinical Trial Transparency

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Manager, Clinical Trial Transparency to join our diverse and dynamic team. As a Manager, Clinical Trial Transparency at ICON, you will play a pivotal role in ensuring the compliance and ethical transparency of clinical trial data, promoting accountability in the research process. You will contribute to the advancement of innovative therapies by overseeing the timely registration and reporting of clinical trial information.

What You Will Be Doing:

Leads and establishes the process for either the redaction/anonymization activities of personal data/company confidential information in clinical documents according to applicable guidelines and local laws as well as ensures timely delivery of anonymization reports when applicable
Participates to the development and maintenance of the commercial confidential information (CCI) strategy in close collaboration with the content experts and coordinates the CCI redactions/anonymization and preparation of justification documents as needed and the general translation and translation validation strategy of submission relevant documents in close collaboration with content experts to assure the maintenance of translation convention and consistency of high-quality submission documents
Organizes a kick-off meeting for a clinical data transparency submission and trains relevant functions within sponsor on the processes and guidelines
Coordinates cross-functional teams, run comment resolution-meetings as required, develop a project plan (including required resources and cost planning), track and communicate progress and address and escalate issues as required
Maintains and updates the rules for the personal data redaction/anonymization according to local laws and regulatory authority guidelines as applicable
Trains relevant functions within sponsor on applicable submission processes and guidelines
Manages the vendor interactions for the relevant submission documents
Provides document management expertise to all redaction/anonymization or translation validation related processes and ensures all deliverables are provided according to set timelines and with excellent quality
Ensures all deliverables are provided according to set timelines and with excellent quality
Interfaces with Health Authority in collaboration with sponsor regulatory, as needed (e.g. Health Canada PRCI PIM Meeting)
Trains new colleagues as needed.

Your Profile:

The candidate must have at least a Bachelor degree, advanced degree is preferred and at least 5 years of experience in the pharmaceutical industry.
The incumbent must have strong English and communication skills, both written and verbal are essential and global working experience is preferred
The incumbent should have excellent electronic document management and IT-skills and willingness to test and implement new tools and platforms for redaction/anonymization tasks and processes.
The incumbent must be able collaborate effectively in teams and feel comfortable interacting with people in all hierarchy levels.
Ability to work efficiently, precisely and independently.
Experience in project management, process development and/or coordination.
Vendor management experience

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

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Manager - Clinical Trial Transparency

Job Description

Manager - Clinical Trial Transparency

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