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 (https://clarkstonconsulting.com/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 (https://clarkstonconsulting.com/diversity/) to learn more about our diversity initiatives.