Sso Study Start-up Manager

6 months ago

กรงเทพมหานคร, Thailand PRTR Full time

Our client is a leading global provider of Pharmaceuticals. This company is comprised of professionals who are passionate about their role in bringing their Medicine to their customers worldwide.

This position is responsible for coordinating and ensuring timely start-up activities, and maintaining communication with local Health Authorities. You will work closely with the global study team and local stakeholders to ensure that study start-up activities align with country commitments and are completed on schedule.
- Collaborating with the Team Lead and Country Head Portfolio/ Cluster Head Portfolio to support the country's Study Start-Up strategy.
- Working with the Country/Cluster Head Portfolio, Portfolio Team Leads, and the global study team to ensure that timelines and deliverables align with country commitments.
- Taking accountability for timely start-up activities, starting from country allocation to achieving the milestone, indicating readiness to initiate site activities. Closely communicate with local Institutional Review Boards/Independent Ethics Committees and Health Authorities.
- Ensuring that all study start-up activities are completed on schedule, including preparing IRB/IEC submission packages, reviewing Informed Consent Forms, and coordinating with Regulatory Affairs/CTA Hub for Health Authorities submissions, when necessary.
- Preparing and finalizing local submission packages for IRB/IEC, CTA Hub (Europe: as per new EUCTR guidelines), and applicable Health Authorities, including amendments, Investigator's Brochures (IBs), Development Safety Update Reports (DSURs), and Clinical Study Reports (CSRs).
- Collaborating with local and global stakeholders to respond promptly to deficiency letters and coordinate reportable events and notifications to IRB/IEC and Health Authorities, as needed.
- Ensuring the accuracy, quality, and timely maintenance of country Trial Master File (TMF) documents during the study start-up phase, ensuring inspection readiness.
- Adhering to financial standards, prevailing legislation, ICH/GCP guidelines, IRB/IEC requirements, Health Authority regulations, and standard operating procedures (SOPs).
- Implementing innovative and efficient processes aligned with strategic goals.
- Supporting feasibility studies in collaboration with the Feasibility Manager, Site Partnership Manager, and the global study team. If assigned, lead site selection, in coordination with the Portfolio Team Lead and Clinical Project Manager.

**Requirements**:

- A degree in a scientific or health-related field.
- Experience in clinical trials and project management.
- Minimum 5 years experience in clinical operations (project management/monitoring clinical trials).
- Fluent in English.

  • Study Start-up Manager for Biopharma Department

    6 months ago

    กรุงเทพมหานคร, Thailand AstraZeneca Full time

    **Study Start-Up Manager** **Job Summary**: The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the company procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations. The SSU Manager will prepare, review, track and manage site...

  • Study Start-up Manager, Smm Oncology

    6 months ago

    กรุงเทพมหานคร, Thailand AstraZeneca Full time

    **Job summary**: The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the company procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations. The SSU Manager will prepare, review, track and manage site regulatory documentation at...

  • Senior Study Start Up Associate

    3 months ago

    กรุงเทพมหานคร, Thailand Icon plc Full time

    Study Start Up Associate - Thailand, Bangkok - Office Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior...

  • Study Start Up Associate

    6 months ago

    กรุงเทพมหานคร, Thailand ICON Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Study Start Up Associate

    7 months ago

    กรุงเทพมหานคร, Thailand ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Study Start Up Associate Ii

    7 months ago

    กรุงเทพมหานคร, Thailand ICON Full time

    Job Advert Posting - At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. - Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability...

  • Study Start Up Associate I

    6 months ago

    กรุงเทพมหานคร, Thailand ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery,...

  • Senior Study Start Up Associate

    6 months ago

    กรุงเทพมหานคร, Thailand ICON Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Senior Study Start Up Associate

    7 months ago

    กรุงเทพมหานคร, Thailand ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Study Start Up Associate Ii

    7 months ago

    กรุงเทพมหานคร, Thailand ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Start-up Manager

    6 months ago

    กรุงเทพมหานคร, Thailand Lotus Bakeries Full time

    Thailand- BangkokAre you an experienced and innovative professional seeking an exciting opportunity to shape the success of a new greenfield factory? We are currently looking for a Strategic Start-Up Manager to join our dynamic team and lead the team in establishing our cutting-edge facility. This pivotal role requires an individual with exceptional...

  • Start-up Manager

    8 months ago

    กรุงเทพมหานคร, Thailand Lotus Bakeries Full time

    Thailand Bangkok Are you an experienced and innovative professional seeking an exciting opportunity to shape the success of a new greenfield factory? We are currently looking for a Strategic Start-Up Manager to join our dynamic team and lead the team in establishing our cutting-edge facility. This pivotal role requires an individual with exceptional...

  • Study Support Assistant

    7 months ago

    กรุงเทพมหานคร, Thailand ICON Full time

    Job Advert Posting - At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. - Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability...

  • (Start-up) Project Manager

    7 months ago

    กรุงเทพมหานคร, Thailand HydroNeo (Thailand) Co., Ltd. Full time

    To expand our activities, we are looking for a Project Manager for our startup. We are looking for a hands-on and pragmatic person who can drive own projects and take over responsibilities for a changing array of business-related tasks and projects. HydroNeo is an international start-up supporting the Thai aquaculture industry with a focus on shrimp...

  • (Start-up) Project Manager

    7 months ago

    กรุงเทพมหานคร, Thailand HydroNeo (Thailand) Co., Ltd. Full time

    To expand our activities, we are looking for a Project Manager for our startup. We are looking for a hands-on and pragmatic person who can drive own projects and take over responsibilities for a changing array of business-related tasks and projects. HydroNeo is an international start-up supporting the Thai aquaculture industry with a focus on shrimp...

  • Marketing Manager

    6 months ago

    กรุงเทพมหานคร, Thailand Curtain Up Drama and Magic Full time

    Marketing Manager Part-time role Monday, Wednesday and Friday 8am to 5pm Reporting to: Business Owner Department: Marketing Location: Ekkamai The marketing manager will play a key role in the successful delivery of the company’s projects and activities. They’ll work closely with the company director, graphic designer and web developer as well as the...

  • Study Startup Associate

    6 months ago

    กรุงเทพมหานคร, Thailand PSI CRO Full time

    **Company Description** We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to...

  • Clinical Lead

    8 months ago

    กรุงเทพมหานคร, Thailand Novotech Asia Full time

    This position is open to all APAC countries including AU and NZ. **Brief Position Description**: The Clinical Lead (CL) and Senior Clinical Lead provides direction and guidance to multi-country clinical teams in assigned project(s), coordinates site management and monitoring activities, and provides operational leadership for clinical teams to achieve...

  • Project Manager for Sustainable Eco Start Up

    7 months ago

    วัฒนา, กรุงเทพมหานคร, Thailand Northstar Full time

    **Company Overview**: Eco Elevate is a forward-thinking group of startups focused on sustainable living and environmental harmony. Our portfolio includes ventures in bamboo construction, an eco-resort, bamboo harvesting and manufacturing, and furniture production. All our companies are in their startup phase, embodying our commitment to sustainable practices...

  • Clinical Research Associate Ii

    4 weeks ago

    กรุงเทพมหานคร, Thailand Parexel Full time

    **Key Accountabilities**: **Start-up (from site identification through pre-initiatio**n**: Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. - Build relationships with investigators and site staff. - Conduct, drive and manage country specific feasibility and/or site...