Clinical Operations Senior Consultant

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 Senior Consultant 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 Senior Consultant at Clarkston you will:  

• Contribute to the implementation of risk-based Good Clinical Practices (GCP)
• Plan, identify, coordinate, and execute 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
• Support the audit of 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
• Earn trusted client status and develop relationships that extend beyond the project’s lifecycle
• Conduct knowledge transfer and training of end-users, including sharing best practices
• Provide guidance to junior analysts and client personnel assigned to projects

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

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 

• Direct experience working with TMF, CTMS, EDC, RTSM, etc. with a strong acumen of processes required; hands-on system experience preferred
• Working knowledge of FDA regulations and guidelines, ICH, GxP manufacturing and clinical trials
• At least 2 years of direct study management work preferred
• Experience with the development of supporting SOP’s and standards  
• Experience writing clinical documents such as protocols, ICF, and/or CSR required
• Experience leading a team of collaborative clinical professionals  
• Excellent oral, written, and medical communication skills
• Ability to facilitate discussions and negotiate mutually beneficial solutions
• Excellent communication and presentation skills
• ASCM (formerly APICS) and/ or ISM certification a plus
• Flexibility and adaptability - our Senior Consultants work on everything from design to hands-on configuration and can stretch into new roles
• Thorough client services orientation and accustomed to taking an active role in executing engagements and project plans/tasks
• Excellent analytical skills and the ability to present and write at a publication-quality level to communicate findings and recommendations
• 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.  

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 learn more about our diversity initiatives.