Clinical Operations and Compliance Project Manager

Clarkston Consulting is seeking 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. Come join us as a Clinical Operations and Compliance Project Manager, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries.

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.  

What You’ll Do  

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, and 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
• Develop and implement SOPs
• Audit clinical research organizations, clinical laboratories and investigator sponsored trials
• Perform training and education of global GCP standards 
• Review clinical and data operational plans and protocols

How You’ll Grow  

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

• Receive the support and mentorship of your Clarkston colleagues and leaders
• Expand your existing skillset with internal and external professional development opportunities

Requirements

What We’re Looking For 

• Minimum of 6 years of increasing recent leadership experience in clinical drug development in the pharmaceutical/biotech industry  
• Excellent knowledge of Good Clinical Practices and local country regulations: 

• Good Clinical Data Management Practices 
• HIPAA – Protected Health Information/GDPR-General Data Protection Regulation 
• Drug Development and Regulatory Approval Processes 

• At least 2 years of direct study management work preferred
• At least 1-2 years of recent experience in risk-based monitoring 
• Experience with the development of supporting SOP’s and standards  
• Strong computer acumen in technology applications, including but not limited to, use of eTMF, EDC, CTMS, site EMR systems, etc.
• 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  
• Excellent oral, written, and medical communication skills
• 4-year degree from an accredited college or university

Travel Requirement 

Travel is an integral part of this role and is estimated to average 30-50%. This may vary based upon client and project needs. When not traveling, consultants work from their home office. Relocation is not required.  

More About Clarkston 

 Founded in 1991, Clarkston Consulting delivers technology and management solutions to market leaders in the life sciences, consumer products, and retail industries. At Clarkston, we cultivate success - for our clients, for our people, and for our firm. We utilize a team approach leveraging our collective expertise and industry knowledge to solve our clients’ business challenges.  

Benefits

Our benefits include:  

• Comprehensive Health and Wellness Benefits (Medical, Dental, Vision, and more)  

• 401k with company contributions  
• Paid vacation, personal days, holidays, and sick leave  
• Paid Parental Leave and Family Building Benefits (Adoption, Surrogacy, and Infertility Support) 
• Life and Disability Insurance 
• Training and Professional Development investments, Tuition Assistance, and more 

Visit Careers at Clarkston to learn more about our culture, benefits, and opportunities. 

Clarkston Consulting is an equal opportunity employer. We are committed to ensuring our firm is rich in diverse skills, competencies, strengths, personalities, and culture. We foster an inclusive environment that embraces the unique contributions of our people to further our purpose. Please visit Diversity @ Clarkston to lea