Clinical Lead

2 months ago


บางกอกนอย กรงเทพมหานคร, Thailand Novotech Asia Full time

**Responsibilities**:

- Lead site identification and site selection activities.
- Lead set up of clinical components in CTMS
- Prepare for and attend investigator meetings; may present materials.
- Develop and distribute Clinical Monitorring Plan (CMP) and update as required
- Develop and distribute Site Initiation Visit (SIV) materials.
- Develop and distribute Source Data Verification/Monitoring tools and trackers.
- Develop and distribute annotated report templates and templates for visit confirmation/follow-up letters in accordance with any Sponsor requirements.
- Review Site Activation Forms and related essential documents; assist PM and/or Regulatory Start-up Manager (RSM) with Project and Country Activation Forms as requested across regions.
- Work with PM and/or RSM to coordinate initial shipment of both IP and non IP supplies across regions. Work with PM for re-supply of IP and non-IP.
- Lead the CRA team to ensure all study materials are in place before SIV.
- Lead internal meetings/teleconferences with the CRA team.
- Ensure the clinical team are adequately trained on project-specific requirements.
- Review CTMS compliance reports for clinical project team and follow up on gaps.
- Review Monitoring Visit Reports (MVR) and follow-up letters for compliance with ICH-GCP and the CMP; provide final approved documents to Sponsor as required and track report metrics in CTMS.
- Track the resolution of follow-up issues from site visits.
- Maintain protocol deviation tracking in CTMS
- Ensure appropriate issue escalation and tracking of these to resolution, proactive identification of areas of risk, and develop risk management strategies.
- Oversee safety reporting processes to ensure in line with regulatory requirements.
- Provide guidance to CRAs and IHCRAs through mentoring.
- Oversee data collection and query resolution throughout the projects.
- Oversee and coordinate the timely review and documented reconciliations of the TMF at the indicated timepoints per the project filing plan.
- Assist PM with response to audit findings and assist the clinical team with completion of any CAPA review and documentation.
- Work with PM to manage clinical resources to ensure monitoring activities are within budget and notify the PM of any changes required or changes in scope.
- Assist PM to oversee the timely completion of site and investigator payment in accordance with the schedule detailed in the Clinical Trial Agreement.
- May perform co-monitoring visits for ensuring site quality and CRA's monitoring performance as request.
- Oversees study transition plans of CRAs, ensures filing of the transition document/checklist.
- Coordinate with PM and CRAs for Database Lock (DBL) and all close-out activities.
- Oversee site close-out activities of the CRA team


  • Clinical Lead

    2 months ago


    กรุงเทพมหานคร, Thailand Novotech Asia Full time

    **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 deliverables. **Minimum Qualifications & Experience**: -...

  • Clinical Lead

    3 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...

  • Clinical Team Lead

    2 months ago


    กรุงเทพมหานคร, Thailand Fortrea Full time

    Clinical Team Leads (CTL) own the clinical delivery of clinical research trials. CTLs function as the Clinical Project Manager (CPM) within the core project team. CTLs partner with the Project Manager and other functional leads to ensure successful delivery of the clinical aspects of a trial within contractual and budgetary requirements. The CTL oversees the...

  • Sr Cra I

    1 week ago


    กรุงเทพมหานคร, Thailand Syneos - Clinical and Corporate - Prod Full time

    **Description** **Senior Clinical Research Associate I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and...

  • Clinical Trainer

    2 weeks ago


    กรุงเทพมหานคร, Thailand Novotech Asia Full time

    **Brief Position Description**: Clinical Trainer is primarily responsible for assisting Clinical L&D Manager in training curriculum development including material development (user manuals, reference guides, iHelp, training videos, FAQs, Workflows etc), maintenance and formal delivery to internal/external users for all applicable clinical trainings. The...


  • กรุงเทพมหานคร, Thailand MSD Full time

    **Job Description**: This position is responsible for project management of the assigned studies, accountable for performance for assigned protocols, leads local study teams to high performance on trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert etc. **WHAT YOU WILL DO** **Key Responsibilities**: -...


  • สาทร, กรุงเทพมหานคร, Thailand PRTR Full time

    More than just a recruitment company. At PRTR, we have been a part of our customer's success for 30 years as their total HR solutions partner. With 550 dedicated professionals and over 15,000 outsourced staff, we will continue to carry out our mission to develop a better career, a better life, and a better society, and thrive to become the No.1 people...


  • กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

    PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our global...


  • กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...

  • Local Study Lead

    3 weeks ago


    กรุงเทพมหานคร, Thailand IQVIA Full time

    To lead Local Study Team at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with sponsor’s Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. The Local Study Lead may perform site monitoring as needed to support the flexible...


  • กรุงเทพมหานคร, Thailand MSD Full time

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality, standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr.COM/COM Lead, the person is responsible for execution and oversight of...


  • กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...


  • กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...


  • กรุงเทพมหานคร, Thailand Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

    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 science a step beyond through...


  • กรุงเทพมหานคร, Thailand Novasyte 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 accordance...


  • กรุงเทพมหานคร, Thailand Novasyte Full time

    Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines - Administer protocol and related study training to assigned sites and...


  • กรุงเทพมหานคร, Thailand MSD Full time

    **Job Description**: **THE OPPORTUNITY** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements...

  • Head of Sales

    3 weeks ago


    กรุงเทพมหานคร, Thailand Connexus Global Full time

    **Responsibilities**: In this role, you will be leading the sales development & management, business development of Clinical Diagnostics business unit. You are accountable for the overall expenses and profitability of the product segment. You will be managing and developing the sales and technical team in Thailand. You will be responsible for managing,...


  • กรุงเทพมหานคร, Thailand MSD Full time

    With support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, the company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. The aCRM could be...