AstraZeneca
GlobalStudyAssociateManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Global Study Associate Manager at AstraZeneca. Skills: study delivery oversight, cross-functional coordination, vendor management, project management. Provide oversight to ensure study delivery. Lead/contribute to preparation of delegated study documents”
What You'll Achieve.
ensure study delivery to time, costs and quality objectives; ensure study is inspection ready at all times; ensure study delivery according to agreed timelines, budget and quality standards
Industry & Context.
risk and issue identification; development of mitigation and/or action plans for identified risks and issues
What They're Looking For.
Must Have
University degree (or equivalent), Relevant experience from within the pharmaceutical industry or similar organization or academic experience, Knowledge of clinical development / drug development process in various phases of development and therapy areas, Excellent knowledge of international guidelines ICH/GCP, Excellent communication and relationship building skills, external service provider management skills, Good project management skills, Demonstrated ability to collaborate as well as work independently, Demonstrated leadership skills, Computer proficiency, advanced computer skills in day-to-day tasks, Experience in all phases of a clinical study lifecycle, Basic knowledge of GXP outside of GCP (i. e GMP/GLP), Excellent verbal and written communication in English
Nice to Have
preferably in medical or biological sciences or discipline associated with clinical research, preferably of at least 3 years
What You'll Do.
Provide oversight to ensure study delivery
Lead/contribute to preparation of delegated study documents
Maintain and facilitate interactions with internal and external functions
Contribute to planning and conduct of internal and external meetings
Ensure supply of Investigational product and study materials
Proactively contribute to risk and issue identification
Ensure study documents are complete and verified for quality
Support Global Study Leader with budget management
Adhere to global clinical processes and guidelines
Support Global Study Leaders in project management
Support Global Study Leader in management of the CRO
Ensure study delivery according to timelines
Maintain and document oversight of the CRO
Take on assignments on non-drug project work
How You'll Work.
Team & Collaboration
In partnership with AZ enablement team, other AZ clinical experts and external service providers; Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance; and external functions including the CROs and other external service providers; Demonstrated ability to collaborate as well as work independently; Supports Global Study Leaders (GSL) in project management; Supports Global Study Leader (GSL) in management of the CRO
Communication Scope
Excellent communication and relationship building skills; Excellent verbal and written communication in English
Process & Methodology
Good project management skills, Supports Global Study Leaders (GSL) in project management as per agreed delegation, Project Manager to ensure study delivery according to agreed timelines, budget and quality standards
Full Job Description
**Typical Accountabilities:** \- In partnership with AZ enablement team, other AZ clinical experts and external service providers, the GSAM provides oversight to ensure study delivery. \- Leads/contributes to the preparation of delegated study documents (e.g. Informed Consent Form, Master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.) \- Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives \- Contributes to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting) \- Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate \- Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues \- Ensures that all study documents in scope of GSAM’s responsibilities are complete and verified for quality in Trial Master File \- Supports Global Study Leader (GSL) with budget management, such as external service provider invoice reconciliation \- Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times \- Supports Global Study Leaders (GSL) in project management as per agreed delegation \- For outsourced studies, supports Global Study Leader (GSL) in management of the CRO \- Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, o while ensuring that the appropriate level of oversight of the CRO
Applying for this Global Study Associate Manager role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about AstraZeneca?
Real rants from real employees. Read before you apply.