An immediate opening is available for a seasoned Clinical Study Manager within US HIV Investigator Sponsored Studies group. The Investigator Sponsored Study manager will be responsible for the day-to-day study operations and other administrative aspects of research conduct so that scientists can focus on delivering high quality relevant research supporting HIV medicines marketed by their healthcare partner. The ISS (Investigator-Sponsored Studies) Study Manager must have be highly organized and disciplined, able to manage information on multiple studies at multiple stages of completion on time and to budget using appropriate systems and tools to track, monitor, and report progress and metrics relating to these activities. Individual will interact closely with internal matrix partners (global ISS team, regulatory affairs, global outsourcing, regional medical scientists, global medical affairs operations, etc.) and external partners (investigators and site personnel) to ensure delivery of research on time and to budget.
Our client is a science-led global healthcare company with a mission to improve the quality of human life by enabling people to do more, feel better, and live longer. They are committed to tackling the three "priority" diseases identified by the World Health Organization: HIV/AIDS, tuberculosis, and malaria. Their business employs over 97,000 people in over 100 countries. Around 12,500 people work in our clients research teams in the UK, USA, Spain, Belgium, and China to discover new medicines.
- Accountable for ensuring all studies follow relevant SOPs and GCPs.
- Coordinate global pre-review process for new study proposals.
- Negotiates site budgets and contracts using Fair Market Value tools.
- Facilitate development of contracts for approved studies to ensure appropriately defined milestones meet internal metrics and ABAC due diligence.
- Responsible for oversight and maintaining accuracy of central study files and electronic study database in accordance with guidelines.
- Enter in-scope studies into eTrack; confirm accuracy of data monthly via eCOMPS.
- Responsible for liaising with study sites to manage and track study progress against timelines.
- Track and phase study budgets and overall study budget including monthly updates in Hyperion.
- Coordinates and track updates for periodic safety updates and NDA annual reports for products.
- Process, track, and forecast drug orders or clinical trial material for approved studies.
- Ensure invoice payments and tracking in Savion
- Coordinate and track drug substance requests by product.
- Update and/or develop tracking reports on timelines and statuses of deliverables and budgets from approved studies for leadership.
- Work with Director to ensure compliance with appropriate policies and identify areas of improvement.
- Represent HIV ISS on internal process improvement teams (e.g. ISS Quality Council) and update relevant stakeholders.
- A Bachelors Degree or equivalent experience is required.
- Five or more years experience in study or project management.
- Experience with HIV studies and/or Investigator-Sponsored Studies (ISSs).
- Experience in pharmaceutical industry or health related field.
- Proficiency in multiple systems and software applications (e.g., eTrack, Hyperion, Sharepoint, Excel, Powerpoint, Business Objects, etc ) is required.
- Knowledge of clinical development process is desired.
- Able to perform study-related project management tasks, working in collaboration with study scientists.
- Experience working on multiple studies, including complex projects assignments in a matrix environment.
- Strong Powerpoint, Sharepoint, and Business Objects skills.
- Demonstrated ability to manage multiple studies delivering on time and to budget.
- Ability to be strongly organized and prioritize work with stakeholders.
- Ability to identify and recommend process improvements.
- Awareness of Level 1 compliance and Level 2 assurance is desired.
- Individual must have customer service orientation, proven problem solving, negotiation, and interpersonal skills.
- Individual must be able to understand and follow company processes and procedures, SOPs and ISS guidelines.
Discover all that's possible with Yoh. Apply now.
Recruiter: Zachary Stewart
Phone: (215) 299-8109
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn more about our company.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
Deadline: Contact employer