Clinical Trial Transparency Manager

Russell Tobin; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

Join a forward-thinking organization as a Remote Clinical Trial Transparency Manager, where you'll drive excellence in scientific staffing. This role involves preparing essential documents for clinical trial applications and collaborating with key stakeholders to enhance transparency processes. With a commitment to innovation and quality, this opportunity allows you to make a significant impact in the pharmaceutical industry while enjoying the flexibility of a remote position. If you have a passion for clinical development and regulatory affairs, this is the perfect chance to elevate your career.

Benefits

Comprehensive Healthcare Coverage

401(k) Retirement Savings

Life & Disability Insurance

Employee Assistance Program

Identity Theft Protection

Legal Support

Auto and Home Insurance

Pet Insurance

Employee Discounts

Qualifications

• 3+ years in Clinical Development or regulatory affairs required.
• Experience with EMA Policy 0070 and EU clinical trial regulations.

Responsibilities

• Prepare redacted documents for Clinical Trial Applications.
• Collaborate with stakeholders on scheduling and tracking deliverables.

Skills

Clinical Development

Regulatory Affairs

Clinical Trial Disclosure

Global Clinical Transparency Regulations

ICH-GCP Knowledge

Education

Bachelor’s Degree in Scientific/Medical Discipline

Job description

Get AI-powered advice on this job and more exclusive features.

This range is provided by Russell Tobin. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70.00/hr - $79.00/hr

Direct message the job poster from Russell Tobin

Senior Manager- Scientific: Driving excellence in Scientific and Technical staffing.

The Scientific Team at Russell Tobin & Associates is supporting a top pharmaceutical organization in the Philadelphia, PA area that has an opening for a Remote Clinical Trial Transparency Manager.

Responsibilities

• Participate in Transparence Strategy meetings and prepare 536/2014 redacted documents for Clinical Trial Applications (CTA) submissions required to comply with the new 536/2014 Clinical Trial Regulation (CTR).
• Participate in lessons learned activities and provide feedback on the new 536/2014 SOP and work instruction and provide input to required process updates
• Prepare redacted documents as directed for clinical studies conducted in EU that will have transition from CTD to CTR
• Assist establishment of new way of working with redaction and anonymization vendor.
• Collaborate with biostatistics, Programming and other key stakeholders to assist with scheduling and tracking deliverables, development of processes, template and business rules for assets across all therapeutic areas.
• Prepare proposed redaction packages to comply with EMA Policy 0070

Requirements

• Bachelor’s degree in a scientific/medical/pharmaceutical discipline required
• 3+ years’ work experience in a Clinical Development and/or regulatory affairs environment required
• Working experience with global clinical transparency regulations, e.g. EMA Policy 0070, health Canada PRCI, EU clinical Trial Regulation 536/2014
• Understanding of the clinical development process, specifically clinical trial disclosure obligations
• International registration and results posting on clinical trial registries work experience
• Demonstrated experience in clinical trial disclosure and transparency process and systems
• Knowledge of ICH-GCP, awareness of clinical publication practices and standards (i.e. ICMJE).

Additional Notes:

• 100% remote but must be in Eastern Time Zone. Local candidates to Philadelphia, PA area preferred.
• Position type: 1 year contract with potential for extension/conversion.
• Hourly rate approved up to $70-79/hr.

Must be authorized to work in the United States.

Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

APPLY NOW!

About Us

Russell Tobin is a leading minority-owned professional and technical recruitment and staffing advisory organization.

We are comprised of specialized practices focusing on a variety of skill sets and industries. Having a depth and breadth of industry expertise, our subject matter experts are able to provide tailored and swift sourcing solutions to fulfill client hiring needs. In other words, we connect top talent with companies.

We are the staffing arm of the Pride Global network, a minority-owned integrated human capital solutions firm, with additional offerings in vendor management, payroll programs, and business process optimization.

As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance, Research, and Science

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at Russell Tobin by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified when a new job is posted.

Sign in to set job alerts for “Clinical Trial Manager” roles.

United States $130,000.00-$145,000.00 3 days ago

Thousand Oaks, CA $40.00-$45.00 2 weeks ago

United States $100,000.00-$135,000.00 1 week ago

United States $140,000.00-$150,000.00 2 weeks ago

United States $150,000.00-$170,000.00 1 week ago

Clinical Project Manager – East Coast, USA | Remote

Boston, MA $80,000.00-$95,000.00 4 weeks ago

Clinical Research Marketing Manager- 182825

United States $85,000.00-$100,000.00 1 week ago

Regional Clinical Study Manager - Oncology/ Solid Tumor

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.