Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead. * Contributes to patient recruitment strategy including ...
Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead. * Contributes to patient recruitment strategy including ...
The Associate Global Study Manager balances administrative coordination with hands-on, customer-facing study support, acting as an extension of the Global Study Manager in maintaining accurate ...
The Associate Global Study Manager balances administrative coordination with hands-on, customer-facing study support, acting as an extension of the Global Study Manager in maintaining accurate ...
The Associate Global Study Manager balances administrative coordination with hands-on, customer-facing study support, acting as an extension of the Global Study Manager in maintaining accurate ...
The Associate Global Study Manager balances administrative coordination with hands-on, customer-facing study support, acting as an extension of the Global Study Manager in maintaining accurate ...
Local Study Associate Director- FSP
Chesapeake, VA · On-site
$110 - $170/hr
Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead. * Contributes to patient recruitment strategy including ...
New
Local Study Associate Director- FSP
Chesapeake, VA · On-site
$110 - $170/hr
Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead. * Contributes to patient recruitment strategy including ...
New
Local Study Associate Director - FSP
$34.25 - $46.75/hr
Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead. * Contributes to patient recruitment strategy including ...
Local Study Associate Director - FSP
$34.25 - $46.75/hr
Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead. * Contributes to patient recruitment strategy including ...
Initiates, monitors, and closes study sites in compliance with AstraZeneca Procedural Documents ... Good cultural awareness and ability to work within global teams. * Proficiency with clinical ...
Initiates, monitors, and closes study sites in compliance with AstraZeneca Procedural Documents ... Good cultural awareness and ability to work within global teams. * Proficiency with clinical ...
Office based minimum 3 days per week AstraZeneca is a global, science-led, patient-focused ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Office based minimum 3 days per week AstraZeneca is a global, science-led, patient-focused ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Office based minimum 3 days per week AstraZeneca is a global, science-led, patient-focused ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Office based minimum 3 days per week AstraZeneca is a global, science-led, patient-focused ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Office based minimum 3 days per week AstraZeneca is a global, science-led, patient-focused ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Office based minimum 3 days per week AstraZeneca is a global, science-led, patient-focused ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Office based minimum 3 days per week AstraZeneca is a global, science-led, patient-focused ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Office based minimum 3 days per week AstraZeneca is a global, science-led, patient-focused ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Global Development Senior Medical Director, Hematology Oncology
Cambridge, MA · On-site
$288.06 - $432.09/hr
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Global Development Senior Medical Director, Hematology Oncology
Cambridge, MA · On-site
$288.06 - $432.09/hr
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the ... Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical ...
Global Study Management Associate (gSMA)
$72K - $97K/yr
Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial Management Associates and other key stakeholders globally and regionally * Knowledgeable of clinical ...
Global Study Management Associate (gSMA)
$72K - $97K/yr
Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial Management Associates and other key stakeholders globally and regionally * Knowledgeable of clinical ...
Empowered to act on smart risks, you will translate strategy into decisive studies, accelerate ... Why AstraZeneca: Here, science and courage go hand-in-hand. You will work on one of the most ...
Empowered to act on smart risks, you will translate strategy into decisive studies, accelerate ... Why AstraZeneca: Here, science and courage go hand-in-hand. You will work on one of the most ...
Empowered to act on smart risks, you will translate strategy into decisive studies, accelerate ... Why AstraZeneca: Here, science and courage go hand-in-hand. You will work on one of the most ...
Empowered to act on smart risks, you will translate strategy into decisive studies, accelerate ... Why AstraZeneca: Here, science and courage go hand-in-hand. You will work on one of the most ...
We are seeking aClinical Study Associate Managerto join ourClinical Trial management team.In this ... with global study plans, and may contribute to global planning and management of the study
We are seeking aClinical Study Associate Managerto join ourClinical Trial management team.In this ... with global study plans, and may contribute to global planning and management of the study
We are seeking aClinical Study Associate Managerto join ourClinical Trial management team.In this ... with global study plans, and may contribute to global planning and management of the study
We are seeking aClinical Study Associate Managerto join ourClinical Trial management team.In this ... with global study plans, and may contribute to global planning and management of the study
We are seeking aClinical Study Associate Managerto join ourClinical Trial management team.In this ... with global study plans, and may contribute to global planning and management of the study
We are seeking aClinical Study Associate Managerto join ourClinical Trial management team.In this ... with global study plans, and may contribute to global planning and management of the study
Global Study Associate Astrazeneca information
See salary details
$17.31 - $22.12
4% of jobs
$22.12 - $26.92
8% of jobs
$26.92 - $31.73
12% of jobs
$31.88 is the 25th percentile. Wages below this are outliers.
$31.73 - $36.54
26% of jobs
$36.54 - $41.35
18% of jobs
$43.02 is the 75th percentile. Wages above this are outliers.
$41.35 - $46.15
19% of jobs
$46.15 - $50.96
6% of jobs
$50.96 - $55.77
2% of jobs
$55.77 - $60.58
1% of jobs
$60.58 - $65.38
1% of jobs
$65.38 - $70.19
2% of jobs
$17
$39
$70
How much do global study associate astrazeneca jobs pay per hour?
What does a typical day look like for a global study associate at AstraZeneca?
As a Global Study Associate at AstraZeneca, your typical day involves supporting global clinical study operations by maintaining study documentation, coordinating with internal teams and external vendors, and tracking study milestones. You'll often attend team meetings, update tracking systems, assist with regulatory submissions, and respond to queries from various stakeholders. The role requires close collaboration with clinical project managers, data managers, and other departments to ensure studies stay on schedule and adhere to compliance standards. This dynamic environment provides continuous learning and development opportunities.
What are the key skills and qualifications needed to thrive as a global study associate at AstraZeneca?
To thrive as a Global Study Associate at AstraZeneca, you need a solid understanding of clinical research processes, attention to detail, and a relevant scientific degree. Familiarity with clinical trial management systems (CTMS), regulatory guidelines like ICH-GCP, and experience using tools such as Microsoft Office and electronic data capture platforms are important. Strong organizational, problem-solving, and communication skills help you navigate cross-functional teams and global projects effectively. These competencies ensure accurate study support, compliance, and seamless collaboration within complex, international research environments.
What is a global study associate at AstraZeneca?
A Global Study Associate (GSA) at AstraZeneca supports the execution of clinical studies by coordinating administrative and operational tasks. This role involves collaborating with cross-functional teams, maintaining study documentation, and ensuring compliance with regulatory requirements. GSAs assist in study planning, tracking progress, and managing logistics to help deliver high-quality clinical trials. They play a crucial role in ensuring studies run smoothly and meet company and regulatory standards.

Parexel rating
8.2
Based on 13 frontline employees who took The Breakroom Quiz
29th of 73 rated research
Job description
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
PXL FSP is seeking LSADs in the US! This is a remote role. Oncology experience is required for this role and cell therapy is strongly preferred!
The Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
The LSAD may perform site monitoring as needed to support the flexible capacity model.
The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Trial and Site Administration
- Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
- Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction).
- Sets up and maintains the study in CTMS at study country level and local websites as required by local laws and regulations.
- Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Reviews monitoring visit reports (as required and following Client SOPs) and pro-actively advises the monitor(s) on study related matters.
- Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
- Proactively identifies risks and facilitates resolution of complex study problems and issues.
- Organizes regular Local Study Team meetings on an agenda driven basis.
- Actively works towards achieving good personal relationships with all Local Study Team members, sites' staff and global stakeholders.
- Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead.
- Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
- Develops, maintains and reviews risk management plans on country study level; proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
- Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
- Plans and leads National Investigator meetings, in line with local codes, as required.
- Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
- Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and client Procedural Documents.
- Plans and leads activities associated with audits and regulatory inspections in liaison with Clinical Quality Associate Director (CQAD) and QA.
- Provides input to process development and improvement.
- Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
- Updates Line Managers about the performance of the CRAs/CSAs.
- Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
- Collaborates with local Medical Affairs team.
- Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management
Document Management
- Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
- Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.
- Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF "Inspection Ready".
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
Regulatory and Site Start Up Responsibilities
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
- Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level.
Budgeting, Agreements and Payments
- Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).
- Ensures timely preparation of local Master Clinical Study Agreement (CSA) (including site budget) and amendments as needed.
- Ensures accurate payments related to the study are performed according to local regulations and agreements.
Compliance with Sponsor Standards
- Ensures compliance with Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Ensures that study activities at country level comply with local policies and code of ethics.
- Completes timesheets accurately as required.
Compliance with Parexel Standards
- Complies with required training curriculum.
- Completes timesheets accurately as required.
- Submits expense reports as required.
- Updates CV as required.
- Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
Skills (Essential):
- Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
- Excellent project management skills.
- Excellent team building and interpersonal skills.
- Excellent organizational skills.
- Excellent verbal and written communication skills.
- Excellent ability to prioritize and handle multiple tasks.
- Excellent attention to detail.
- Proficient in written and spoken English language required.
- Fluency in local language(s) required.
- Good negotiation skills.
- Good ability to learn and to adapt to work with IT systems.
Skills (Desirable):
- Good analytical skills.
- Good resource management skills.
- Good decision making and delegation skills.
- Good financial management skills.
- Basic change management skills.
- Basic coaching skills.
- Basic ability in handling crisis situations.
Knowledge and Experience (Essential):
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
Knowledge and Experience (Desirable):
- Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
- Good knowledge of the Drug Development Process.
- Excellent understanding of the Clinical Study Process including monitoring.
- Very good understanding of the Study Drug Handling Process and the Data Management Process.
- Good intercultural awareness.
Education:
- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
Other:
- Ability to travel nationally and internationally as required.
- Integrity and high ethical standards..
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
About PAREXEL
Sourced by ZipRecruiter
Bring your Data Management expertise to Parexel's Strategic Partnerships. Although we work globally, each partnership we form is deeply personal. We are as dedicated to every aspect of our client's product development as they are - and work closely with client teams in true partnership to understand both challenges and opportunities. At Parexel we are focused on meeting customer and patient needs through collaborative partnership so that we get treatments into the hands of patients who need them most.
Industry
Pharmaceutical and medicine manufacturing
Company size
10,000+ Employees
Headquarters location
Waltham, MA, US
Year founded
1983