Kelly Services Clinical Study Manager in Troy, Michigan

Kelly’s Outsourcing & Consulting Group is seeking a candidate for a Clinical Study Manager. This is a 2+ year assignment with benefits and can be based in Troy, MI or Jacksonville, FL. The Clinical Study Manager reports to the Senior Operations Manager of KellyOCG’s Functional Service Provider (FSP) program providing centrally managed solutions and operational across the US and EMEA. The FSP program supports positions in Regulatory Affairs, Clinical Operations, Medical Affairs, Data Management and others. The Clinical Study Manager maintains customer relationships, manages macro-level employee performance and development, and contributes to the overall support of workforce teams.

RESPONSIBILITIES:

Customer Relationships

  • Maintain regular contact with clients/employees to ensure satisfaction surrounding existing program performance and workforce output

  • Collect and disseminate client feedback through appropriate KOCG channels to service client needs

  • Maintain program health for existing clients and employee

Personnel Functional Management

  • Review Candidate CVs (as needed)

  • Conduct candidate Interviews (as needed)

  • Maintain regular contact with employees to ensure the following:

  1. program processes are understood

  2. training needs are recognized and addressed

  3. professional development plans/opportunities are defined and guided

  • Conduct formalized semi-annual and annual performance evaluations

  • Confer with Senior Operations Manager to coordinate raises and bonuses

Operations Management

  • Manage the strategic planning of study conduct in conjunction with product development, ensuring that operating procedures and company policies are followed.

  • Manage timelines, resourcing and budget for supporting platform clinical trials.

  • Provide rationale for decisions, present strategies in a clear message and drive clinical study execution with Platform leads.

  • Mentor/facilitate successful study team behavior.

  • Partner with Platform Managers and Research Optometrists/Clinicians/Biostatisticians to ensure that project deliverables are met.

  • Manage relationships externally with Strategic Partners, including universities, research institutions and Contract Resource Organizations (CROs).

  • Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable regulations and guidelines required to gain approval for testing investigational Medical Devices.

  • Perform CRA management activities and any related duties as assigned.

  • Participate in or lead on-site face to face customer/employee meetings

  • Participate in client sales cycle initiation calls or meetings

  • Conduct Governance reporting and QBR meetings through direct presentation or other media as requested

  • Support KellyOCG with business development activities

QUALIFICATIONS

  • Accredited college degree required (Bachelor’s degree) Life Science focus preferred

  • Master’s Degree preferred if Bachelors not in Life Sciences

  • 5+ years of experience as a Clinical Research Associate in the pharmaceutical or medical device industry

  • 2+ years direct employee management experience or equivalent experience required leading initiatives within the following fields:

  • Regulatory/Medical Affairs industry experience or training

  • Clinical Operations industry experience or training

  • Marketing/ Recruiting

  • Working knowledge of device or drug development process preferred

  • Must be detail oriented, technologically savvy, highly independent, and capable of working in a flexible environment

  • Excellent oral and written communication skills

  • Entrepreneurial spirit and a willingness to learn and grow with a new, expanding program

  • Willingness to travel up to 50% in US/EMEA

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

This position comes with enhanced benefits which include:

  • 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

  • Paid holidays

  • Paid sick days and vacation days*

Perks of being a Kelly employee:

  • Weekly electronic pay

  • Access to more than 3,000 online training courses though Kelly Learning center

  • Online application system

  • Never an applicant fee

*benefits to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.