Study Start-up Manager, Smm Oncology Unit
3 days ago
**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 regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.
**Typical Accountabilities**:
- Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Actively participates in Local Study Team (LST) meetings.
- Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
- Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that 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 enrol, and in line with AZ SOPs.
- Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
- Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
- Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.
**Upon local decision, additional responsibilities may include**:
- Prepare, review and negotiate contracts with investigational sites being the primary point of contact for investigational sites to ensure the contracts are fully executed
- Support site selection process by identifying and assessing potential sites/investigators
- Assist in initial forecasting for budget, study materials and drug supplies. Plan applicable local drug activities (local purchase or reimbursement)
**Minimum Requirements and Preferred Background**:
- Minimum University degree, preferred in Pharmacy or healthcare-related field.
- Minimum 5 years’ experience in Clinical Operations
- Excellent knowledge of spoken and written Thai and English.
- Good ability to learn and to adapt to work with IT systems.
- Good project management, decision-making, coaching, interpersonal, negotiation skills.
- Excellent communication skills, verbal and written and presentation skills.
-
กรุงเทพมหานคร, Thailand AstraZeneca Full time**Job Summary**: The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. **Typical Accountabilities**: -...
-
Senior Study Start-up Associate
2 weeks ago
กรุงเทพมหานคร, Thailand ICON plc Full timeAt 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 I
4 days ago
กรุงเทพมหานคร, Thailand ICON plc Full timeAt 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,...
-
Local Study Lead
22 hours ago
กรุงเทพมหานคร, Thailand IQVIA Full time**Responsibilities**: - 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 optimises the performance of the Local Study Team(s) at country level ensuring compliance with sponsor’s...
-
Country Study Manager
2 weeks ago
กรุงเทพมหานคร, Thailand Thermo Fisher Full timeManages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage...
-
(Start-up) Project Manager
2 days ago
กรุงเทพมหานคร, Thailand HydroNeo (Thailand) Co., Ltd. Full timeTo 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...
-
District Sales Manager
1 week ago
กรุงเทพมหานคร, Thailand Takeda Pharmaceutical Full time**Job Title: District Sales Manager** **Location: Thailand, Bangkok** **About the role**: Develops and leads a team of Sales Specialty Representative to achieve or exceed sales goals and business objectives by effectively develop business plan, execute sales activities, monitor performance, coach and motivate the sales team efficiently within the framework...
-
Clinical Study Administrator
3 weeks ago
กรุงเทพมหานคร, Thailand AstraZeneca Full timeTypical Accountabilities: - Provides technical expertise to clinical trials staff within AstraZeneca within the area of study management - Supports with the administrative aspects of the study process - Works within establish frameworks to deliver a variety of tasks that support projects in meeting their objectives - Conducts a wide range of often complex...
-
Brand Executive
2 weeks ago
กรุงเทพมหานคร, Thailand Nestle Operational Services Worldwide SA Full time**POSITION SNAPSHOT**: Location: Bangkok, Pathumwan Company: Nestlé Business Unit/Division: Nestlé Professional Full-time Bachelor’s Degree in Marketing or related Minimum 2 years of experience in brand management focus on Marketing activation and inovation Good English & Thai communication skill is a must **A DAY IN THE LIFE...**: - Activation of Food...
-
Clinical Lead
3 days ago
กรุงเทพมหานคร, Thailand Novotech Asia Full timeThis 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
3 weeks 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...
-
Medical Representative, Oncology Lung Team
3 days ago
กรุงเทพมหานคร, Thailand AstraZeneca Full timeMedical representative responsible for selling a specific product or group of products. Technical expert of specific company products, therapeutic classes or patient needs, calling on specialists. Typically establish long-term relationships with key customers. Generally have prior experience in pharmaceutical sales. **Typical Accountabilities**: -...
-
Chief, Conference Management Unit
5 days ago
กรุงเทพมหานคร, Thailand United Nations (UN) Full timeEfficient operation of the United Nations Conference Centre, Bangkok (UNCC) and leading and/or providing oversight to various projects designed to enhance functioning of the UNCC;. Effectively managing the Conference Management Unit and its human and financial resources and providing one-stop conference support services to ESCAP, UN and external clients in...
-
Assistant Cra
4 weeks ago
กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time**Assistant CRA - Thailand** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking...
-
Clinical Research Associate
2 days ago
กรุงเทพมหานคร, Thailand IQVIA Full time**Job Overview** Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. **Essential Functions** - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Manager, Risk Management
4 weeks ago
กรุงเทพมหานคร, Thailand PricewaterhouseCoopers Consulting Ltd. Full timeCoordinating and monitoring compliance with local regulatory requirements. Implementing risk management processes, which includes reviewing completion of client and engagement acceptance, completion of client and job code creation, completion of vendor assessment, and/or reviewing relevant risk management processes as assigned on an ad-hoc basis. Performing...
-
Clinical Research Associate
3 days ago
กรุงเทพมหานคร, Thailand Grand Pacific CRO Full time**About Us**: **The Grand Pacific CRO** team has over 25 years’ experience in conducting clinical trials in the Asia Pacific region, including Australia, New Zealand and South Africa. We have continued as a leader in the industry and have expanded services to include central laboratory, site management and image reading services. We pride ourselves on...
-
Product Manager
3 days ago
กรุงเทพมหานคร, Thailand MSD Full time**Job Description**: **Job Purpose**: This position needs to monitor business performance and external environment via appropriate tools to deliver corrective action as required to meet business objectives including designs and develops marketing tools/programs that fulfill the activities described in product marketing plans. Product Manager will report to...
-
Strategic Account Manager
4 weeks ago
กรุงเทพมหานคร, Thailand Try & Review Full time**Key Responsibilities** - Work hand-in-hand with the company directors to support them in sustaining and reinforcing existing relationships with current or past large and strategic clients - Maintain HubSpot up-to-date records for assigned contacts and companies, keeping the latest data into the system - Develop trustful relationships with a portfolio of...
-
Business Unit Lead
6 days ago
กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full timeA member of the Thailand Country Leadership Team. Provides overall business directions and leadership in assigned business franchises and business development team based on subsidiary goals. Develop marketing strategies for the franchise and ensure effective implementation of these strategies in the field. Responsible for the ongoing development and...