Clinical Research Manager

Vivent Health; Denver (CO); On-site; USD 77,000 - 87,000; Full time

Benefits offered by this job

Generous PTO including 12 paid company

401(k) with 100% employer match up to

12 weeks paid parental leave for benef

Employer-subsidized medical, dental, &

Tuition reimbursement and licensure

Benefits for full-time and eligible部分

Job summary

Vivent Health is seeking a Clinical Research Manager to oversee the operational management, regulatory compliance, quality, and performance of the clinical research program. You will work with Principal Investigators, healthcare providers, sponsors, CROs, and internal stakeholders to evaluate opportunities, ensure readiness, and support study execution.

You will guide staff development, ensure GCP and HIPAA compliance, manage data systems, contribute to budgeting, and travel as needed to support

Qualifications

• Minimum of 5 years of progressively responsible clinical research experience, including experience in clinical research operations and in an environment dealing with research and funding, required.
• Minimum of 2 years of experience leading and developing people; fostering a collaborative, mission driven team environment that supports high-quality care and community impact required.
• Demonstrated experience supervising or managing clinical research personnel required.
• Experience working with sponsors and/or CROs required.
• Experience with clinical research study start-up and feasibility assessment required.
• Current GCP and human subjects protection training (such as CITI) required, with renewal as required by the IRB and sponsors.

Responsibilities

• Lead day-to-day operations of the clinical research program, including staffing, workload, and resource allocation.
• Supervise, coach, and develop research staff, set performance expectations, and ensure training, competencies, and credentials stay current.
• Oversee the study portfolio from feasibility and start-up through conduct and close-out, including operational feasibility assessments, readiness for study activation, and records retention.
• Develop and maintain research policies, SOPs, and workflows that support consistent, compliant practice.
• Ensure research is conducted in accordance with GCP (including ICH E6(R3)), IRB requirements, approved protocols, sponsor requirements, and applicable regulations, and protect participants through oversight of informed consent, privacy (including HIPAA), and timely adverse event reporting.
• Oversee quality management, data integrity, and inspection readiness, including preparation for sponsor, CRO, and regulatory monitoring visits and audits.
• Review protocol deviations and other compliance issues, lead corrective and preventive action plans, and elevate significant compliance or participant-safety concerns to the Principal Investigator, Clinical Research Director, or other appropriate leaders.
• Oversee participant recruitment and retention across the portfolio, address barriers, and promote equitable access for populations historically underrepresented in clinical research.
• Oversee research data collection and management systems (such as CTMS, EDC, and eRegulatory) and report program metrics to the Clinical Research or Medical Director.
• Partner with Principal Investigators, Medical Directors, providers, Pharmacy, and laboratory teams to integrate research into clinical care with minimal disruption, including investigational product accountability.
• Serve as primary operational liaison with sponsors, CROs, and research partners, and elevate significant sponsor, contractual, financial, or strategic matters to the Clinical Research Director.
• Participate in study budget development and review, monitor financial performance and research billing compliance, and work with Finance, Legal, and Compliance on Clinical Trial Agreements, invoicing, and participant payments.
• Support the Clinical Research Director in implementing research strategy and building a sustainable, high-quality program.
• Travel to other locations as needed.

Skills

Leadership

Communication

Project management

Problem-solving

Collaboration

Adaptability

Education

Bachelor’s degree in health sciences, life sciences, public health, healthcare administration, business administration, nursing, research, or related discipline

Tools

MS Office

Databases

Electronic data capture (EDC)

Job description

YOUR CONTRIBUTION:

Deliver Excellence. Oversee with Integrity. Drive Progress. Exceed Expectations.

The Clinical Research Manager is responsible for the operational management, regulatory compliance, quality, and performance of the clinical research program. This position oversees the implementation and management of clinical research studies, research personnel, and the systems and processes needed to support high-quality, compliant, and efficient research operations.

The Clinical Research Manager works collaboratively with Principal Investigators, healthcare providers, clinical and operational leaders, sponsors, Contract Research Organizations (CROs), and other internal and external stakeholders to evaluate research opportunities, ensure organizational readiness, support successful study execution, and integrate research activities into clinical operations. The Clinical Research Manager also supports the financial sustainability and continued development of the clinical research program.

OUR EXPECTATIONS:

Winning skills and behaviors for success.

• Lead day-to-day operations of the clinical research program, including staffing, workload, and resource allocation.
• Supervise, coach, and develop research staff, set performance expectations, and ensure training, competencies, and credentials stay current, including training for new research staff.
• Oversee the study portfolio from feasibility and start-up through conduct and close-out, including operational feasibility assessments, readiness for study activation, and records retention.
• Develop and maintain research policies, SOPs, and workflows that support consistent, compliant practice.
• Ensure research is conducted in accordance with GCP (including ICH E6(R3)), IRB requirements, approved protocols, sponsor requirements, and applicable regulations, and protect participants through oversight of informed consent, privacy (including HIPAA), and timely adverse event reporting.
• Oversee quality management, data integrity, and inspection readiness, including preparation for sponsor, CRO, and regulatory monitoring visits and audits.
• Review protocol deviations and other compliance issues, lead corrective and preventive action plans, and elevate significant compliance or participant-safety concerns to the Principal Investigator, Clinical Research Director, or other appropriate leaders.
• Oversee participant recruitment and retention across the portfolio, address barriers, and promote equitable access for populations historically underrepresented in clinical research.
• Oversee research data collection and management systems (such as CTMS, EDC, and eRegulatory) and report program metrics to the Clinical Research or Medical Director.
• Partner with Principal Investigators, Medical Directors, providers, Pharmacy, and laboratory teams to integrate research into clinical care with minimal disruption, including investigational product accountability.
• Serve as primary operational liaison with sponsors, CROs, and research partners, and elevate significant sponsor, contractual, financial, or strategic matters to the Clinical Research Director.
• Participate in study budget development and review, monitor financial performance and research billing compliance, and work with Finance, Legal, and Compliance on Clinical Trial Agreements, invoicing, and participant payments.
• Support the Clinical Research Director in implementing research strategy and building a sustainable, high-quality program.
• Travel to other locations as needed.
• This job description is not all-inclusive and outlines the main responsibilities and requirements of the role. Employees may be asked to perform additional job-related tasks as needed.
• Adhere to all agency policies, including but not limited to Confidentiality, Employee Handbook, Health Care Corporate Compliance Plan, Standards of Conduct, training, and other relevant policies.

NOTE: Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

LEADERSHIP:

Leadership is the ability to inspire, influence, and guide others towards achieving a common and/or strategic goal or vision. It involves several key elements:

• Vision and Direction: A leader has a clear idea of where they want to go and communicates this vision effectively to others.
• Motivation: Leaders inspire and motivate their team members, encouraging them to give their best effort and stay committed to the goals.
• Decision Making: Effective leaders make informed decisions, often considering input from their team while taking responsibility for the final choices.
• Communication: Communication skills are crucial for leaders to articulate their vision, provide feedback, and foster collaboration among team members.
• Empathy and Emotional Intelligence: Leaders understand and relate to the emotions of others, building trust and creating a positive work environment.
• Accountability: Good leaders take responsibility for their actions and decisions, setting a standard of accountability for themselves and their team.
• Adaptability: In a dynamic environment, leaders must be flexible and adaptable, adjusting strategies and approaches as needed to achieve success.
• Collaboration: Leaders model collaboration, engage teams and drive partnerships across departments to transfer knowledge, enhance decision-making and improve results.

KNOWLEDGE REQUIRED:

Required and preferred knowledge and experiences to succeed.

• Education:
  • Bachelor’s degree in health sciences, life sciences, public health, healthcare administration, business administration, nursing, research, or a related discipline required. Master’s degree preferred.
• Work Experience:
  • Minimum of 5 years of progressively responsible clinical research experience, including experience in clinical research operations and in an environment dealing with research and funding, required.
  • Minimum of 2 years of experience leading and developing people; fostering a collaborative, mission driven team environment that supports high-quality care and community impact required.
  • Demonstrated experience supervising or managing clinical research personnel required.
  • Experience working with sponsors and/or CROs required.
  • Experience with clinical research study start-up and feasibility assessment required.
• Licensure/Certification:
  • Clinical research certification such as ACRP-CP, CCRC, CCRP, or equivalent preferred; in-progress status is acceptable.
  • Phlebotomy certification preferred; in-progress status is acceptable.
  • Current GCP and human subjects protection training (such as CITI) required, with renewal as required by the IRB and sponsors.
• Technical Experience:
  • Proficiency with MS Office, Windows, and databases required.
  • Experience with the IRB approval process and research study protocols required.
  • Strong knowledge of GCP, IRB requirements, informed consent, clinical trial operations, research documentation, and regulatory compliance required.
  • Experience with clinical trial management, electronic data capture, or electronic regulatory systems preferred.
• Soft Skills:
  • Demonstrated leadership, communication, project-management, and problem-solving skills required.
  • Ability to build effective working relationships with investigators, clinicians, sponsors, and community partners, and to elevate issues appropriately.
  • Commitment to participant protection, confidentiality, and respectful, inclusive engagement with people affected by HIV.
• Additional Preferred Qualifications:
  • HIV experience in a not-for-profit environment.
  • Experience managing industry-sponsored clinical trials.
  • Experience with clinical research budgets, contracts, and financial management.
  • Experience establishing or expanding a clinical research program.
  • Experience conducting research within community health, nonprofit healthcare, infectious diseases, or populations historically underrepresented in clinical research.

STATEMENT OF INCLUSION:

Vivent Health is an equal opportunity employer and will recruit, hire, promote, and transfer qualified persons into all job classifications regardless of race, gender, religion, skin color, national origin or ancestry, physical disability (including pregnancy), mental disability, age, gender identity, sexual orientation, legally protected medical condition, family care status, marital status, veteran status, genetic characteristics, or any other characteristic protected by federal or state law. Vivent Health complies with other expanded protected classifications that specific county or municipal regulations may mandate.

Vivent Health is deeply committed to fostering respect, dignity, and understanding for all individuals affected by HIV, regardless of race, ethnicity, sexual orientation, gender identity, socioeconomic status, or any other characteristic. We are dedicated to cultivating a supportive and inclusive environment that champions advocacy, education, and compassionate care for everyone in our diverse community.

Going beyond the law’s requirements, Vivent Health places great importance on fostering a culture that celebrates diversity, equity, inclusion, and belonging. We actively seek qualified candidates from different racial, cultural, and economic backgrounds, as we believe that differing perspectives and experiences make us stronger as an organization. Vivent Health encourages all interested persons to apply for this position, and we look forward to learning more about your unique background and qualifications.

As a recipient of federal funding, Vivent Health will not hire nor enter a contractual relationship with any party debarred, suspended, or excluded from federal assistance programs.

$ 77,000/annually - $87,000/annually (Depending on Experience)

The final salary will be determined based on factors such as market data, internal equity, candidate experience and qualifications. Please note that it is uncommon for an individual to be hired at or near the top of the range.

• Generous PTO, including 12 paid holidays
• 401(k) with 100% employer match up to 5%
• 12 weeks fully paid parental leave for benefits-eligible employees after one year
• Employer-subsidized medical, dental, vision, and gender-affirming care
• Tuition reimbursement and licensure assistance
• Benefits for full-time and eligible part-time roles

Public Student Loan Forgiveness

Employment at our organization may qualify you for federal student loan forgiveness programs. We do not directly pay for – nor forgive – federal student loans; however, our status as a not-for-profit organization under Section 501 (c) (3), makes us an eligible employer. There may be other determining factors for one to qualify.

Please follow this URL to review one such program and their requirements:

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.