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 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 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.
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.
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 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 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 learn more about our diversity initiatives.