Global Study Manager, Early Oncology Clinical
Global Study Manager, Oncology R&D, Early Oncology Clinical
Type: Hybrid ( 3 days On site, 2 days Remote)
Location: Waltham, MA or Gaithersburg, MD
The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.
- Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
- Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
- Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process.
- Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data. Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
- Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
- Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
- Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
- Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.
- Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
- Support risk management and quality efforts to ensure study compliance.
- Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
- Prepare presentation material for meetings, newsletters and websites.
- Support the study team in the implementation of audits and regulatory inspections.
- Contribute to review of new/amended/unique SOPs and guidance documents.
Education, Qualifications, Skills and Experience
- Bachelor's Degree and 3+ years of experience, Associate's degree plus 7+ years of experience or High School plus 11+ years of experience
- Experience of working with and delivering through strategic partners and 3rd party vendors
- Excellent knowledge of ICH-GCP principles
- Team orientated
- Ability to coordinate and prioritize multiple tasks and deliverables
- Proactive approach
- High degree of flexibility
- Demonstrated verbal and written communication skills
- Good negotiation and collaboration skills
- Demonstrated interpersonal and problemsolving skills
- Some travel may be required
- Early phase oncology clinical trial experience
- Global study management experience
- Key Relationships to reach solutions
Closing Date15-Feb-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.