Top 15 Clinical trial administrator Jobs in Exton, Pa

Associate Director, Clinical Trial Disclosure & Transparency
CSL —King of Prussia, PA
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- Senior level
Senior Clinical Trial Case Manager
CSL —King of Prussia, PA
- Full-time
- 7 years
- Master's degree
- Bachelor's degree
14d
Clinical Trial Liaison
ICON Plc —Blue Bell, PA
- Full-time
- Remote
- Mid-level
- Analysis skills
- Bachelor's degree
- Disability insurance
- Health insurance
20h
Clinical Trial Associate
KPS Life —Malvern, PA
- Microsoft Excel
- 5 years
- Organizational skills
8d
Clinical Trial Lead
Novocure —Wayne, PA
- $147,000 - $190,000 a year
- Full-time
- Hybrid work
- Nursing
- 5 years
- Office
Associate Director, Clinical Trial Disclosure & Transparency
CSL Behring —King of Prussia, PA
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- Senior level
Clinical Development Trial Lead
ICON Plc —Blue Bell, PA
- Full-time
- Remote
- Bachelor's degree
- Training & development
- Senior level
- Disability insurance
- Health insurance
Clinical Trial Manager
KPS Life —Malvern, PA
- Nursing
- Anatomy knowledge
- 5 years
8d
Senior Clinical Trial Manager
OCUGEN OPCO INC —Malvern, PA
- 7 years
- Office
- Bachelor's degree
- Opportunities for advancement
Clinical Trial Manager
OCUGEN OPCO INC —Malvern, PA
- 5 years
- Office
- Bachelor's degree
- Opportunities for advancement
Clinical Trial Rater - Borderline Personality Disorder
IQVIA —Philadelphia, PA
- Part-time
- Remote
- LMFT
- Medicine
- Psychiatry
- Work from home
4d
EDC Clinical Trial Designer
ICON Plc —Blue Bell, PA
- Full-time
- Remote
- Computer Science
- Mid-level
- Continuous improvement
- Disability insurance
- Health insurance
1d
Associate Director, Clinical Trial Lead, Clinical Operations
Cabaletta Bio —Philadelphia, PA
- Bachelor of Science
- 8 years
- Bachelor's degree
- Health insurance
- Paid time off
3d
Clinical Trials Manager
Nemours —Wilmington, DE
- Full-time
- Nursing
- Management
- RN License

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Associate Director, Clinical Trial Disclosure & Transparency

CSL -
King of Prussia, PA

Apply Now

Job Details

Full-time

Qualifications

Vendor relationship building
Compliance risk assessment
Drug regulation
Legislative impact assessment
GDPR compliance expertise
ICH guidelines
Vendor compliance management
Clinical research compliance
Bachelor's degree
Pharmaceutical company experience
Vendor performance improvement
Vendor relationship management
Leading team collaboration initiatives
Regulatory compliance analysis
Cross-functional team management
Project stakeholder communication
Cross-functional communication
FDA regulations

Full Job Description

The Associate Director Clinical Trial Disclosure and Transparency is a global subject matter expert responsible for ensuring timely, accurate, and compliant clinical trial disclosures across all regions and study types (interventional and observational). This role guides global strategy, drives process excellence, and oversees the delivery of clinical trial disclosure activities including registration, results disclosure and layperson summaries while providing support for transparency activities including anonymization and redaction of commercially confidential information (CCI) as required for business continuity and operational needs. All activities and deliverables must be conducted in alignment with international regulations, CSL policies, industry standards and transparency requirements.

Key Responsibilities

Strategic Oversight & Compliance

Lead enterprise clinical trial disclosure and transparency strategy and advise therapeutic areas and Medical Affairs on global requirements (e.g., FDAAA 801 and the Final Rule, clinicaltrials.gov, CTIS, EU CTR 536/2014, UK Clinical Trials Regulations 2025 (MHRA), EMA Policy 70, Health Canada PRCI)

Monitor emerging regulatory and industry trends and influence CSL's disclosure and transparency strategy accordingly. Develop and implement scalable, efficient processes that meet evolving regulatory and industry standards

Serve as the primary liaison to public registries (e.g., ClinicalTrials.gov, CTIS, EU PAS).

Disclosure Execution

Oversee and deliver high-quality, compliant disclosures including study registration, protocol amendments, summary results, and lay-person summaries

Ensure timely communication of disclosure obligations to clinical teams, affiliates, and stakeholders

Support CROs and local teams with regional disclosure needs

Transparency Execution

Support transparency activities, including the preparation and delivery of compliant redacted document packages for public release by global Health Authorities, ensuring appropriate business continuity across the disclosure and transparency function.

Provide input on transparency obligations and best practices, including promotion of Smart Authoring practices, to clinical teams and functions

Cross Functional Engagement

Partner with Clinical Development, Biostats, Medical Writing, Regulatory, IP, Legal, Data Privacy and CMO staff to embed disclosure and transparency requirements across the development lifecycle

Collaborate closely with other CMO Office team members to ensure effective knowledge sharing, operational continuity and seamless execution of interconnected activities

Represent CSL’s disclosure and transparency practices internally and externally, ensuring alignment with global standards and expectations

Vendor Management

Select, manage, and oversee disclosure and transparency vendors to ensure high-quality deliverables and on-time execution

Drive process improvement, innovation and operational excellence in disclosure activities

Optimize resourcing and technology to support cost-effective delivery

Metrics & Monitoring

Track, analyse and report key metrics to demonstrate compliance, identify risks and drive continuous improvement

Education Requirements

10+ years in pharmaceutical/biotech environment with deep knowledge of the drug development process
Strong judgement, initiative and ability to operate independently as the global subject matter expert responsible for clinical trial disclosure activities
Demonstrated ability to independently interpret emerging regulations, assess business impact, identify compliance risks and develop practical, business-focused recommendations.
Proven track record in managing global disclosure and transparency deliverables. Demonstrated ability to lead through influence in a matrix environment without direct reporting authority
Excellent written and verbal communication skills, with the ability to translate complex regulatory requirements into clear guidance for stakeholders at all levels.
Strong influencing skills and ability to communicate confidently with senior stakeholders, study teams and external vendors.
Ability to constructively challenge stakeholders and vendors, provide evidence-based recommendations and maintain professional credibility in complex discussions
Strong critical thinking skills, with the ability to make decisions and recommendations in ambiguous situations, escalating appropriately when required.
Strong understanding of ICH-GCP, ICMJE, GDPR and industry best practices
Demonstrated experience providing strategic oversight of vendors, critically reviewing recommendations and maintaining accountability for final decisions
Hands on experience with the use and administration of the Trialscope Disclose system (or equivalent)

Education Requirement

Bachelor’s degree in a scientific, medical, or pharmaceutical discipline required

This role requires working in office 3 days per week. #LI-Hybrid

Apply Now

Refine Your Search

clinical trial administrator jobs in exton, pa

Associate Director, Clinical Trial Disclosure & Transparency

Senior Clinical Trial Case Manager

Clinical Trial Liaison

Clinical Trial Associate

Clinical Trial Lead

Associate Director, Clinical Trial Disclosure & Transparency

Clinical Development Trial Lead

Clinical Trial Manager

Senior Clinical Trial Manager

Clinical Trial Manager

Clinical Trial Rater - Borderline Personality Disorder

EDC Clinical Trial Designer

Associate Director, Clinical Trial Lead, Clinical Operations

Clinical Trials Manager

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