McKesson Clinical Trial Manager in The Woodlands, Texas
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Specialty Health, our products and services span the full continuum of specialty patient care. From the initial phases of a product life cycle and the distribution of specialty drugs, to fully integrated healthcare technology systems, practice management support, and ultimately to patient care in the communities where they live, we empower the community patient care delivery system by helping community practices advance the science, technology and quality of care.
We have a vision —that the long-term vibrancy of community care will be achieved through the leadership of physicians committed to clinical excellence and innovation, enabled by close collaboration with our organization and our deep clinical, operational and technological expertise.Every single McKesson employee contributes to our mission—by joining McKesson Specialty Health you act as a catalyst in a chain of events that helps millions of people all over the globe. You’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
Join our team of leaders to begin a rewarding career.
Responsible for the overall execution of clinical trials (projects), accountable for the study start-up activities and timeline management, organization, administration and execution of the clinical trial from start to finish, within the US Oncology Research network in compliance with GCP, IHC, SOPs, internal/departmental guidelines. Works collaboratively with individuals cross-functionally across the organization. Primary contact for sponsors/CRO and vendors. Primary contact for the Network PI and Local PI’s in USOR. Anticipates and identifies potential issues and creates contingency plans. Prioritizes activities with competing deadlines and provides strategic input to projects to ensure goals are met. Recommends leads and implements tactical process improvements. Responsible for contributing to a culture of process improvement, performance measures, project prioritization, and developing successful solutions Provides clear direction, with timelines for supporting members of the project (budget, contracts, regulatory, pricing, network operations, others). Provides supporting members with information they need to successfully complete their job for the CTM. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.
Manage the study star- up process including site list delivery, team process report completion, project map with clear timelines for the project and all supporting team members accountable to the project. Responsible to outline expectations to internal teams and sponsor/vendors to ensure successful study implementation.
Protocol Review: review clinical trials for scientific merit as well as operational review for staff working in an outpatient community based setting. Review protocol procedures for standard of care vs. research related charges. Provide all supporting team members with the information and contacts they need in order to complete their tasks.
Responsible for execution of clinical trials within the USOR network, from initial medical director & associate director approval until final study closure.
Communicate with sponsor/CRO regularly throughout the duration of the study. Communicates clearly and routinely with the sites and associated network operations team regarding status of the project (at least monthly).
Oversee development and maintenance of USOR study tools (i.e. protocol specific flow sheets, clinical trial information sheets, and training documentation, etc.)
Implement research trials at the practice level and develop formats to ensure successful education of clinical research staff. Facilitates ongoing project training throughout the trial timeline. Serves as the study point of contact for all clinical research staff. All questions related to the protocol, billing, payout, monitoring issues, etc. are directed to the clinical trial manager.
Review project status with the physician disease program leadership and participating sites. Provides the NPI as well as the client, monthly operational reports as well as clear direction on what the NPI needs to do to support the study.
Work closely with network operations managers and regional directors to ensure sites meet study expectations, including but not limited to accrual, data entry and quality, and overall adherence to GCP and USOR SOPs.
Review all monitoring and auditor follow-up letters as well as monitors survey forms for quality indicators. Works with the regional staff and quality assurance team to facilitate quality improvement programs (i.e. plans of actions) related to clinical trials.
Responsible for submitting amendments timely and hold teams accountable to a timeline. Responsible for monitoring data completion and backlog.
Minimum Job Qualifications:
Education/Training – Bachelors degree, or equivalent, in a clinical or scientific discipline plus 5 years of clinical research experience. CCRP, CCRA, CCRC certification is a plus.
Specialized Knowledge/Skills –
Proficiency with computer systems and Microsoft Office Suite (Outlook, Word, Power Point, and Excel) required
Attention to detail and demonstration of quick follow-up to study needs, commits to quality
Interpersonal skills and clear oral and written communication skills. Uses correct grammar, syntax, and format
Demonstrated adaptability, handles day to day work challenges confidently, is willing and able to adjust to multiple demands, shifting priorities; shows resilience in the face of challenges, demonstrates flexibility
Shows work commitment: sets high standards of performance; pursues aggressive goals and works efficiently to achieve them
Environment (Office, warehouse, etc.) – General Office, may require travel by air or automobile approximately up to 10% of the time.
Physical Requirements (Lifting, standing, etc.) – Large percent of time performing computer based work is required.
Benefits & Company Statement
McKesson believes superior performance – individual and team – that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it’s flexible enough to meet the different needs of our diverse employee population.
We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.
But we can’t do it without you. Every single McKesson employee contributes to our mission—whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
McKesson is an equal opportunity and affirmative action employer – minorities/females/veterans/persons with disabilities.
Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
No agencies please.Category: Project Management