Manager, Clinical Trials Operations

BAMF Health
  • Grand Rapids, Michigan
    3 days ago

    Job Description

    Join BAMF Health, where you're not just part of a team; you're at the forefront of a revolution in Theranostics, changing lives for the better. As a member of our global team, you'll contribute to pioneering technology and deliver top-tier patient care.

    Located in the heart of downtown Grand Rapids, our cutting-edge global headquarters resides within the state-of-the-art Doug Meijer Medical Innovation Building. Step into our modern and spacious facilities, where innovation thrives and collaboration knows no bounds.

    Join us in our mission to make Theranostics accessible and affordable for all, and be part of something truly remarkable at BAMF Health.

    Duties and Responsibilities, including but not limited to:

    • Team Management & Oversight: Provide strong leadership to the Coordination Team, ensuring all clinical operations are executed at the highest standards. This includes managing a large team of research nurses, coordinators, nuclear medicine coordinators, and other research roles.
    • Trial Start-up & Launch: Collaborate closely with the start-up and regulatory team to set and achieve aggressive timelines for the launch of new trials, transferring trials from Start Up Team to Coordination Team. Identify potential barriers early and develop solutions to keep the trial launch on track.
    • Recruitment Management: Collaborate with Start Up on the development of recruitment plans for clinical trials.  Responsible for successful execution. Monitor recruitment progress, report on outcomes, and, if necessary, lead efforts to adjust recruitment strategies in consultation with the Principal Investigator (PI), Start-Up, Finance, and Director.
    • Vendor Management: Responsible for the management of vendors, including radiology, laboratory, and other essential services. Work with the Start-Up Team to identify, evaluate, and onboard new vendors as required by trial demands, ensuring all services meet BAMF’s high standards.
    • Process Improvement: Drive continuous improvement initiatives across all clinical operations, focusing on enhancing efficiency, reducing errors, and improving patient outcomes. Implement standardized processes and SOPs across the team.
    • Culture & Team Development: Foster a culture of excellence, accountability, curiosity, respect, and teamwork within the Clinical Trials Team. Invest time in mentoring and developing team members to ensure high morale and retention.
    • Operational Oversight: Oversee daily operations at the Grand Rapids site, ensuring compliance with all regulatory requirements and maintaining the highest standards of patient care.
    • Cross-functional Collaboration: Work closely with other BAMF functional groups, including Regulatory and Start Up, Clinic Team, and Finance to ensure cohesive and efficient trial execution.
    • Data Integrity & Compliance: Ensure the accuracy and integrity of clinical trial data, maintaining strict compliance with regulatory standards and BAMF’s internal policies.
    • Strategic Support for Growth: Provide limited but strategic support to BAMF’s growth into new sites, ensuring that the Grand Rapids site serves as a model of excellence within the RadioNexus network.
    • Reporting & Metrics: Regularly report to the Director of Clinical Trials on key performance indicators, operational challenges, and team dynamics.

    Basic Qualifications:

    • Bachelor’s degree in a health-related field or equivalent required
    • Minimum of 3 years of experience in clinical trials management or coordination required
    • Minimum of 2 years of demonstrated leadership experience, including team leadership, staff mentorship, project oversight, or supervisory responsibilities required
    • A working knowledge of ICH-GCP, FDA regulations, informed consent, adverse event reporting and clinical trial documentation required

    Preferred Qualifications:

    • Master’s degree in Health Sciences, Clinical Research, Nursing, or a related field preferred
    • Oncology, nuclear medicine, or radiopharmaceutical clinical research experience preferred
    • Clinical research certification through ACRP or SOCRA (e.g., CCRC, CCRA, ACRP-CP, or CCRP) preferred
    • Active Registered Nurse (RN) license or other relevant healthcare professional license preferred

    Schedule Details:

    • Employment Status: Full time (1.0 FTE)
    • Hours of work: 8:00 a.m.- 4:30 p.m.
    • Days worked: Monday - Friday

    At BAMF Health, our top priority is patient care. To ensure we are able to drive a Bold Advance Medical Future, we offer a well-rounded benefit package to care for our team members and their families. Highlights include:

    • Employer paid High Deductible Health Plan with employer HSA contribution
    • Flexible Vacation Time
    • 401(k) Retirement Plan with generous employer match
    • Several benefit options including, but not limited to; dental, vision, disability, life, supplemental coverages, legal and identity protection
    • Free Grand Rapids downtown parking

    Disclaimer

    BAMF Health provides equal opportunities to all employees for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.


    BAMF Health will reasonably accommodate qualified individuals with a disability so that they can perform the essential functions of a job unless doing so causes a direct threat to these individuals or others in the workplace and the threat cannot be eliminated by reasonable accommodation or if the accommodation creates an undue hardship to BAMF Health.

    BAMF Health is an Equal Opportunity Employer and will not accept or tolerate discrimination or harassment against any applicant, employee, intern, or volunteer based upon the following characteristics: race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability or handicap, sexual orientation, gender identity/expression, transgender status, genetic information, pregnancy or pregnancy-related status, marital status, veteran status, military service, any application for any military service, or any other category or class protected by applicable federal, state, or local laws.

    Numbers & Facts

    LocationGrand Rapids, Michigan

    Skills

    • Adverse Eventsunmatched
    • Clinical Dataunmatched
    • Clinical Nursingunmatched
    • Clinical Researchunmatched
    • Clinical Study Publicationsunmatched
    • Clinical Trialunmatched
    • Clinical Trial Managementunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Data Qualityunmatched
    • FDA Requirementsunmatched
    • Financeunmatched
    • GCP (Good Clinical Practices)unmatched
    • Health Scienceunmatched
    • Healthcareunmatched
    • ICH Regulationsunmatched
    • Informed Consentunmatched
    • Leadershipunmatched
    • Legalunmatched
    • Maintain Complianceunmatched
    • Mentoringunmatched
    • Metricsunmatched
    • Nuclear Medicineunmatched
    • Oncologyunmatched
    • Operationsunmatched
    • Organizational Skillsunmatched
    • Patient Careunmatched
    • Performance Metricsunmatched
    • Process Improvementunmatched
    • Professional Licenseunmatched
    • Progress Reportsunmatched
    • Project Trackingunmatched
    • Radiologyunmatched
    • Recruiting Strategyunmatched
    • Registered Nurse (RN)unmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Research Nursingunmatched
    • Society of Clinical Research Associates (SoCRA)unmatched
    • Standard Operating Procedures (SOP)unmatched
    • Standards of Careunmatched
    • Startupunmatched
    • Team Lead/Managerunmatched
    • Technical Deliveryunmatched
    • Vendor/Supplier Managementunmatched
    • Vendor/Supplier Selectionunmatched

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