- Provide operational expertise to the Study Team.
- Lead the development of study documents 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.
- Provide mentoring and guidance to the operations team ensuring effective collaboration and communication with the Study Team.
- 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 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 study materials and ensure the appropriate allocation of apheresis/manufacturing slot availability by liaising with Cell Therapy Operations (CTO) 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.
- Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
- Oversee 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.
- Drive risk management and quality efforts to ensure study compliance.
- Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
- Prepare presentation material for meetings, newsletters, and websites.
- Direct the Study Team in the implementation of audits and regulatory inspections.
- Identify areas of best practice / process improvements and knowledge share across the Cell Therapy Clinical Group.
- Contribute to review of new/amended/unique SOPs and guidance documents.
- Bachelors Degree and 5+ years of experience, Associates degree plus 9+ years of experience or High School plus 13+ years of experience, of which at least 2 years are in global study management.
- Experience of working with and delivering through strategic partners and 3rd party vendor
- Excellent knowledge of ICH-GCP principles.
- Team orientated.
- Ability to lead, coordinate and prioritise multiple tasks and deliverables.
- Proactive approach to achieving study goals.
- Demonstrated verbal and written communication skills.
- Good negotiation and collaboration skills.
- Demonstrated interpersonal and problem- solving skills.
- Ability to manage change and actively seek and champion more efficient and effective ways of working.
- Ability to coach & act as a buddy for more junior colleagues.
- Some travel may be required.
- Early phase oncology clinical trial experience.
- Experience in autologous or allogeneic oncology therapies
-
Study Manager
3 weeks ago
Aurora Technologies Valley Park, United StatesThe IRE|BS Real Estate Academy GmbH, an affiliated institute of the University of Regensburg, has been offering part-time further education programs for real estate professionals for over 30 years. More than 7,500 national and international students have used our degree programs ...
-
Dual Study Tourism Management
3 days ago
SilverLinx Tamalpais-Homestead Valley, CA, United States Freelance**About us**: · Leonardo Hotels is well positioned for the future as a long-term secure employer and is looking for personalities We live by our motto **BE YOURSELF**. Conformity, strict regulations, and rigid rules are a thing of the past for us. What matters to us is your perso ...
-
FusionTech Francisco, United StatesWe are a medium-sized, continuously growing company in the agricultural sector. Schätz is a technical wholesaler specializing in products for milking technology. For almost 50 years, we have been the contact for specialist retailers. From the Allgäu region, we ship goods througho ...
-
Dual Study Program in Human Resource Management
3 weeks ago
NovaWorks Hercules, United StatesAre you ready to kickstart your career in human resource management? Begin your dual studies with the right practical partner. · Your practical partner - Herzogin Elisabeth Hospital Foundation: · The Herzogin Elisabeth Hospital Foundation in Braunschweig provides care for approxi ...
-
BlueNova Industries East Palo Alto, United StatesSpecialize in Purchasing · Are you about to graduate from high school and want to kickstart your career in the food retail industry? Then our dual study program in food management/purchasing is just right for you. · You will complete the practical phases of the dual study program ...
-
Phoenix Innovations Saranap, United StatesSaranap 'IU International University - Dual Study Program · Innovative and future-oriented teaching and research · Work-life balance · Networking within the faculty at the largest university in Germany · For the winter semester 2024/25, we are looking to fill a professorship (m/f ...
-
Omega Innovations Centerville, United StatesSTART YOUR DUAL STUDIES AT DEUTSCHE POST AG, CENTREVILLE BRANCH IN BERLIN AND THE BERLIN UNIVERSITY OF APPLIED SCIENCES, FOR THE · BACHELOR OF ARTS, BUSINESS ADMINISTRATION-SERVICE MANAGEMENT PROGRAM · You will study Business Administration-Service Management in Berlin. We have r ...
-
Manager, Statistics
2 weeks ago
AbbVie South San Francisco, United States**Company Description** · **Job Description** Key Responsibilities** · - Develop statistical methodology for protocols with details for programming implementation. · - Provide expertise for design, analysis & reporting of clinical trials & other scientific research studies. Imple ...
-
Associate Director, Clinical Business Operations
3 weeks ago
Arsenal Biosciences South San Francisco, United StatesArsenalBio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Associate Director, Clinical Business Operations to work hybrid or remotely.ArsenalBio's mission is to develop efficacious and safe cellular ...
-
Associate Director, Formulation Development
3 weeks ago
Pliant Therapeutics, Inc. South San Francisco, United StatesPliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology a ...
-
Director, Clinical Pharmacology
1 week ago
AbbVie South San Francisco, United States**Company Description** · Purpose · Describe the primary goals, objectives or functions or outputs of this position. · Communicates/presents key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Supports strate ...
-
Apex Ventures Rose Valley, United StatesSHAPE THE FUTURE WITH GFOS AT ROSE VALLEYStrong roots, the power for growth, and a thirst for new challenges – that's GFOS at Rose Valley, a second-generation family business. Since our founding in 1988, we have been striving for excellence and innovation in everything we do. GFO ...
-
Abdera Therapeutics South San Francisco, United States**Who we are** · Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies · - one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform opt ...
-
Animal Care Technician Ii
2 weeks ago
Charles River Laboratories South San Francisco, United StatesWe are seeking anexperienced **Animal Care Technician II **to join our **Insourcing Solutions **team, located **in South San Francisco, CA.** · As the **Animal Care Technician II**, you will observe, monitor, and document the health and physical environment within the Charles Riv ...
-
Regional Clinical Study Manager
6 days ago
BeiGene San Mateo, United States**Position Summary:** · + Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget · + Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts ...
-
Clinical Trial Manager
1 week ago
Vera Therapeutics Brisbane, United States**Title: Clinical Trial Manager** · **Location**:Brisbane, CA** · **About Us**: · Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate ...
-
Clinical Trial Manager Associate
1 week ago
Vera Therapeutics Brisbane, United States**Title: Clinical Trial Manager Associate** · **Location**:Brisbane, CA** · **About Us**: · Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ...
-
Management Assistant
3 weeks ago
US National Archives and Records Administration San Bruno, United States**Duties**: · The following are the duties of this position at the GS-07. If you are selected at a lower grade level, you will have the opportunity to learn to perform all these duties, and will receive training to help you grow in this position. · As a MANAGEMENT ASSISTANT, you ...
-
Clinical Study Data Manager
1 week ago
R&D Partners San Mateo, United StatesOur biopharmaceutical client in the San Francisco Bay Area is recruiting for a Clinical Study Data Manager. Overview: Work within a team in data life-cycle management who acquire and curate data for use in exploratory research, clinical development a Manager, Clinical, Data, Tech ...
-
Program Manager, Study Operations
3 weeks ago
GENERALIST San Francisco, United StatesVerily is a subsidiary of Alphabet · that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, Our purpose is to bring the promise of precision health to everyone, every day. We are focu ...
Senior Global Study Manager - South San Francisco, United States - AstraZeneca
Description
The Senior Global Study Manager, Cell Therapy is responsible for leading the operational activities to support and enable the delivery of cell therapy clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the nature of the clinical program or clinical study, so a high degree of flexibility is required.
Typical Accountabilities
Education, Qualifications, Skills, and Experience
Essential
Desirable
Date Posted
26-Apr-2024Closing Date
23-May-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.
Senior Global Study Manager professionals in South San Francisco
-
Kuo-Ching Chang
Data Scientist
-
David Santos
Technical writer