Advanced Clinical Studies Manager

Job Description

Job Description

Job Title: Advanced Clinical Studies Expert

Job Description

This role leads advanced clinical studies strategy and execution for a rapidly expanding clinical workload, with a strong focus on training and elevating a global clinical affairs team. The Advanced Clinical Studies Expert designs and oversees complex clinical programs, provides high-level consultation on study design and operations, and serves as the central authority on all aspects of clinical affairs within the organization. This position is ideal for a seasoned clinical affairs leader who enjoys mentoring others, shaping strategy, and contributing at an executive level while helping to build organizational capabilities for the long term.

Responsibilities

• Lead the development and implementation of advanced clinical studies strategies to support a rapidly growing clinical workload.
• Train and mentor the global clinical affairs team on all aspects of clinical affairs, including clinical development, clinical operations, and clinical science.
• Design clinical study strategies from the ground up, including selecting appropriate study sites and writing clinical protocols from scratch.
• Provide high-level consultation and strategic input on clinical study design, execution, and optimization across multiple programs.
• Map out end-to-end clinical studies, including planning, timelines, resourcing, and risk identification, to ensure successful delivery.
• Serve as a clinical affairs subject matter expert and challenger, offering critical insight and guidance to senior stakeholders and cross-functional teams.
• Manage and develop clinical teams, providing leadership in clinical management and fostering a culture of excellence and accountability.
• Oversee or advise on clinical trial operations, including site engagement, investigator interactions, and alignment with overall program goals.
• Contribute to the development of clinical documentation, including protocols and related materials, ensuring scientific rigor and clarity.
• Collaborate with key opinion leaders and clinical sites across the United States and potentially Canada to support study execution and scientific partnerships.
• Travel to domestic clinical sites and key opinion leader locations (approximately 25–50% of the time) to support training, oversight, and relationship building.
• Act as a senior-level advisor on clinical affairs topics, drawing on extensive experience in roles such as CRO leadership, director, vice president, executive, or academic professor.

Essential Skills

• 10–15 years of experience in clinical affairs, clinical development, or closely related clinical leadership roles.
• Proven expertise in clinical affairs, including clinical trial design, clinical science, and clinical operations.
• Demonstrated experience managing people and leading clinical teams, including clinical management responsibilities.
• Strong background in building clinical capabilities, including setting strategy and planning for clinical programs.
• Hands-on experience selecting clinical sites and writing clinical protocols from scratch.
• Global clinical experience, with the ability to operate effectively across different regions and regulatory environments.
• Experience mapping out clinical studies end-to-end and providing high-level consultation on study design and execution.
• Advanced proficiency in protocol writing and clinical documentation.
• Strong project management skills in a clinical context, including planning, coordination, and oversight of complex clinical programs.
• Experience in in vitro diagnostics (IVD) or related clinical research domains.
• Ability to challenge assumptions constructively and operate effectively as a high-performing, proactive leader.
• Willingness and ability to travel 25–50% domestically to clinical sites and key opinion leader locations.
• Clear preference for candidates with substantial hands-on clinical leadership experience rather than roles focused solely on monitoring or remote site oversight.

Additional Skills & Qualifications

• Advanced degree in a relevant field; an MBA is highly desirable.
• Extensive executive-level experience, such as serving as a vice president, director, or other senior clinical affairs leader.
• Experience owning or leading a contract research organization (CRO) is highly valued.
• background as a professor or academic leader in advanced clinical affairs or related programs, especially combined with many years of industry experience.
• Interest in a role that may align with the later stages of a career, with a focus on mentoring, knowledge transfer, and strategic guidance.
• Comfort operating in a high-growth environment with a rapidly expanding clinical workload and evolving organizational needs.

Work Environment

This role is based in a laboratory, manufacturing, and clinical office facility in Stillwater, with a minimum requirement of three days per week onsite. The environment combines office-based strategic work with close proximity to laboratory and clinical operations, enabling direct collaboration with cross-functional teams. The position involves regular domestic travel, estimated at 25–50%, to clinical sites and key opinion leader locations across the United States and potentially Canada. The work setting supports hands-on engagement with clinical programs and stakeholders, and it is structured for an experienced professional who is comfortable balancing onsite presence, travel, and high-level strategic responsibilities.

This is a Contract to Hire position based out of Stillwater, MN.

The pay range for this position is $60.00 - $75.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Stillwater,MN.

This position is anticipated to close on Aug 17, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.