Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Practical Nurse (LPN) Experience Required
Germantown, Tennessee, United States · On-site
Mid level
Job Title: Manager, Study Start Up Operations About Us At West Cancer Center, we are committed to advancing innovative cancer research while delivering compassionate, patient-centered care. Our research teams play a crit…
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Full-time
professional certificate
Comprehensive Benefits Package, Professional Development, No Nights, Weekends, or Holidays
Posted 33d ago
~40 hrs/week
Responsibilities
Oversees the strategic and operational management of clinical trial start-up activities, including feasibility, site activation, and sponsor communications. Supervises start-up specialists and coordinates cross-functional efforts between regulatory, contracts, and clinical teams.
Requirements
Requires a current RN or LPN license and a minimum of two years of clinical research experience. Candidates must have strong knowledge of FDA and GCP guidelines and the ability to lead research personnel.
Full job description
Job Title: Manager, Study Start Up Operations
About Us
At West Cancer Center, we are committed to advancing innovative cancer research while delivering compassionate, patient-centered care. Our research teams play a critical role in expanding treatment opportunities and improving outcomes for patients through cutting-edge clinical trials and collaborative research initiatives.
Position Overview
The Manager, Study Start Up Operations is responsible for the strategic oversight, leadership, and operational management of all clinical trial study start-up activities across the research program. This role supervises the Study Start-Up Specialist and Research Specialist positions and serves as the primary operational lead for feasibility, site activation, sponsor communication, start-up timelines, and cross-functional coordination with regulatory, contracts/budgets, data services, and clinical research teams. The Manager ensures efficient activation of clinical trials while maintaining compliance with FDA regulations, GCP guidelines, sponsor requirements, and organizational policies. This position requires a licensed nurse with clinical research experience, leadership ability, and expertise in research processes.
Key Responsibilities
Directly supervises Study Start-Up Specialists and other assigned research start-up personnel
Provides leadership, mentorship, training, and performance management for study start-up staff
Develops departmental workflows, SOPs, and best practices related to study activation and feasibility processes
Serves as escalation point for sponsors, CROs, investigators, and internal departments regarding study start-up issues or delays
Collaborates with Research Leadership to establish departmental goals, activation metrics, and operational priorities
Participates in strategic planning for research growth and study portfolio development
Oversees all study start-up activities from initial feasibility through site activation and handoff to study conduct teams
Reviews and assigns feasibility requests and ensures timely completion of sponsor-required questionnaires
Oversees Confidential Disclosure Agreements (CDAs), protocol review workflows, and study routing processes
Coordinates Research Steering Committee (RSC) and Disease Research Group (DRG) review processes
Monitors study activation timelines and proactively addresses barriers to activation
Oversees Site Qualification Visits (SQVs), Site Evaluation Visits (SEVs), and Site Initiation Visits (SIVs)
Ensures smooth transition of activated studies to Clinical team
Maintains oversight of sponsor communications and manages sponsor expectations throughout the start-up process
Oversees maintenance of staff training records, GCP documentation, and protocol-specific training documentation
Collaborates with contracts/budget and regulatory teams to support timely study activation
Monitors study start-up metrics including activation timelines, pending studies, feasibility outcomes, and sponsor responsiveness
Works collaboratively with investigators, research nursing, regulatory, data management, pharmacy, laboratory, finance, and sponsor representatives
Interfaces with pharmaceutical companies, CROs, and external research partners
Participates in department meetings, sponsor meetings, and organizational initiatives
Maintains professionalism, confidentiality, and ethical standards in all interactions
Supports special projects and strategic initiatives as assigned by Research Leadership
Performs all other duties as assigned
Qualifications
Education & Experience
Required:
Minimum of two (2) years of clinical research experience required
Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial start-up processes
Experience with feasibility assessments, sponsor communications, and study activation workflows
Excellent organizational, analytical, and problem-solving skills
Ability to manage multiple projects and priorities in a fast-paced environment
Strong verbal and written communication skills
Proficient in Microsoft Office applications including Excel, Word, Outlook, and Adobe Acrobat
Preferred:
Experience with CTMS preferred
Credential/Licensure
Required:
Current RN/LPN license required
Work Environment & Physical Demands
Typical clinical and office environment with moderate noise level
Ability to sit, stand, walk, reach, bend, and use hands/wrists for extended periods of time
Ability to effectively communicate verbally and in writing
Ability to lift up to 25 pounds
Occasional travel for investigator meetings, sponsor visits, or conferences may be required
Why West Cancer Center is a Great Place to Work
Meaningful Impact: Play a direct role in supporting patients through one of the most challenging times of their lives.
Collaborative Culture: Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care.
Professional Development: Benefit from ongoing training, educational resources, and growth opportunities.
Mission-Driven Environment: Be part of an organization guided by compassion, integrity, and innovation.
No nights, weekends, or holidays. Comprehensive benefits package.
Join Us
If you are a detail-oriented clinical research professional with leadership experience and a passion for advancing oncology research operations, we encourage you to apply for the Manager, Study Start Up Operations position at West Cancer Center.
Related keywords
Clinical TrialsOncologyFDAGCPCTMSSite Initiation VisitsSite Qualification VisitsSOPFeasibilityCDAClinical Research NursingRNLPNSponsor ManagementCRORegulatory Affairs
MidSouth's leader in comprehensive adult cancer care and research for over 40 years.
Industry
Hospitals and Health Care
Company size
501-1,000 employees
Founded
1978
Headquarters
Germantown, Tennessee
LinkedIn followers
2,845
West Cancer Center & Research Institute is proud to be the region’s comprehensive leader in adult cancer care and research. After delivering 40 years of clinical excellence, our focus still remains the same. We strive to continuously fight for the best outcomes for our patients by offering the most effective, individualized care possible. It’s what sets West apart and why patients from across the region choose West Cancer Center as their trusted partner in their cancer journey.
Our commitment to translate cancer science into revolutionary therapies is furthered by a unique sub-specialization program offering patients and their families true expertise for each cancer type. From breast cancer to liver, lung, brain and so many others – our oncology team provides a comprehensive approach to each disease state. West physicians collaborate together utilizing the knowledge and experience of medical oncologists, radiation oncologists, pathologists, genetic counselors, researchers, and so many others to ensure all treatment options have been discussed and examined in depth for our patients.
West Cancer Center also offers support programs for financial assistance, in-house support groups, and psychology and social work consultations. Our aim is to walk hand-in-hand with our patients throughout their entire journey from diagnosis to treatment while addressing the mind, body and spirit, along with helping eliminate any potential barriers in receiving treatment.
Here at West Cancer Center, you don’t just have cancer. You have West Cancer Center to fight by your side every step of the way.
Offices: 7945 Wolf River Blvd, Germantown, Tennessee 38138, US · 7945 Wolf River, Germantown, Tennessee 38138, US · 271 West Polk Avenue, West Memphis, AR 72301, US · 1588 Union Ave, Memphis, Tennessee 38104, US · 7668 Airways Blvd, Southaven, Mississippi 38671, US
Medical OncologyGynecologic OncologyHead & Neck OncologyMargaret West Comprehensive Breast CenterRadiologyRadiation OncologyClinical ResearchGenetic TestingIntegrative OncologyHospital
MidSouth's leader in comprehensive adult cancer care and research for over 40 years.
Industry
Hospitals and Health Care
Company size
501-1,000 employees
Founded
1978
Headquarters
Germantown, Tennessee
LinkedIn followers
2,845
West Cancer Center & Research Institute is proud to be the region’s comprehensive leader in adult cancer care and research. After delivering 40 years of clinical excellence, our focus still remains the same. We strive to continuously fight for the best outcomes for our patients by offering the most effective, individualized care possible. It’s what sets West apart and why patients from across the region choose West Cancer Center as their trusted partner in their cancer journey.
Our commitment to translate cancer science into revolutionary therapies is furthered by a unique sub-specialization program offering patients and their families true expertise for each cancer type. From breast cancer to liver, lung, brain and so many others – our oncology team provides a comprehensive approach to each disease state. West physicians collaborate together utilizing the knowledge and experience of medical oncologists, radiation oncologists, pathologists, genetic counselors, researchers, and so many others to ensure all treatment options have been discussed and examined in depth for our patients.
West Cancer Center also offers support programs for financial assistance, in-house support groups, and psychology and social work consultations. Our aim is to walk hand-in-hand with our patients throughout their entire journey from diagnosis to treatment while addressing the mind, body and spirit, along with helping eliminate any potential barriers in receiving treatment.
Here at West Cancer Center, you don’t just have cancer. You have West Cancer Center to fight by your side every step of the way.
Offices: 7945 Wolf River Blvd, Germantown, Tennessee 38138, US · 7945 Wolf River, Germantown, Tennessee 38138, US · 271 West Polk Avenue, West Memphis, AR 72301, US · 1588 Union Ave, Memphis, Tennessee 38104, US · 7668 Airways Blvd, Southaven, Mississippi 38671, US
Medical OncologyGynecologic OncologyHead & Neck OncologyMargaret West Comprehensive Breast CenterRadiologyRadiation OncologyClinical ResearchGenetic TestingIntegrative OncologyHospital
