Clinical Operations and Compliance Project Manager

Do you want the opportunity to leverage your skills to make a direct impact on the world’s leading life sciences companies? Join Clarkston Consulting as a Clinical Operations and Compliance Project Manager to help deliver creative business solutions to our market-leading clients as a part of our team of experienced professionals.

We are looking for motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Together, we can help find the answers to our clients most challenging business problems.

What You’ll Do

Clarkston gives you the opportunity to deliver great solutions, become recognized as an industry expert, and help build a great practice.

As a Clinical Operations and Compliance Project Manager at Clarkston, you will:

• Contribute to the implementation of risk - based Good Clinical Practices (GCP) and compliance solutions
• Plan, identify, coordinate, execute, conduct reporting of the implementation of GCP Compliance solutions in support of clinical programs
• Establish/implement clinical quality policies and procedures for Quality Management Systems supporting clinical studies: including CROs, investigator sites, independent studies, central labs, non-clinical study laboratories and other key partners supporting clinical and pharmacovigilance programs
• Provide GCP consultation to clinical study teams
• Develop and implement SOPs
• Audit clinical research organizations, clinical laboratories and investigator sponsored trials
• Ensure that project documents are complete, current, and stored appropriately and must be highly organized, detail-oriented, and meet deadlines
• Perform training and education of global GCP standards, and externally
• Review clinical and data operational plans and protocols

How You’ll Grow

At Clarkston, we feel that we provide the greatest value to our clients through a combination of our industry expertise, business process knowledge, and consulting excellence.

Beyond your day-to-day responsibilities, throughout your career at Clarkston you will:

• Have the support and mentorship of your Clarkston colleagues and leaders
• Own your career – you'll be able to take charge of your career journey with diverse opportunities to lead and expand your skillset both at the client site and within the firm
• Have the opportunity to make a real and positive impact not only the clients you work with, but on the firm as well

Requirements

What We’re Looking For:

An ideal candidate would have the following qualifications and experience:

• Minimum of 6 years of increasing recent leadership experience in clinical drug development in the pharmaceutical/biotech industry
• Excellent knowledge of Good Clinical Practices (ICH Guidelines; Good Quality Practices) and local country regulations (as needed):
  • 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used In Clinical Trials)
  • Good Clinical Data Management Practices
  • HIPAA – Protected Health Information/GDPR-General Data Protection Regulation, as applicable
  • Drug Development and Regulatory Approval Processes (depending on applicable territory(ies)
• At least 2 years of direct study management work preferred
• At least 1-2 years of recent experience in risk-based monitoring preferred
• Excellent knowledge of global GCP regulations, compliance, guidance, and standards
• Experience with the development of supporting SOP’s and standards
• Excellent collaboration and partnering skills
• Ability to work autonomously and as part of a team
• Excellent verbal and written communication skills
• Demonstrated ability to effectively organize and follow through tasks in a timely manner
• Strong computer acumen in technology applications, including but not limited to, use of eTMF, EDC, CTMS, site EMR systems, etc.
• Ability to work in a dynamic, highly collaborative environment
• Clinical Research Professional Certification (ACRP/SOCRA or equivalent) helpful
• Experience in the oversight of all operational aspects of clinical studies
• Experience conducting/managing clinical trials, CROs, multiple vendors, budgets, and timelines
• Experience writing clinical protocols, ICF, and CSR required Experience in oncology and biologics preferred Experience leading a team of collaborative clinical professionals
• Strong leadership skills and self-awareness, with proactive and positive management approach
• Excelle