Clinical Team Lead

An exciting Clinical Team Lead (x1 vacancy) job has just become available at one of the most respected Clinical Research Organisation (CRO) in Thailand.

About the Assistant Brand Manager Role:

Reporting directly to the Clinical Operation Manager, this is a role for a clinical research specialist who is a leader in their field. Your main role is providing direction and guidance to the project team, coordinating site management and monitoring activities, and communicating status of these activities to the Manager. Salary Field: THB110k - 150k per month + bonus + insurance + other benefits

Key Responsibilities:

• Lead country-level operational planning and support site selection within region
• Assist with preparation of initial ethics and regulatory submission package and oversight on approval processes and timelines as well as assist with and track the ethics and regulatory submission and approval processes during the course of the study in CTMS
• Support PM with application and tracking Investigational Product (IP) and ancillaries import/export permits and licenses. Work with PM to coordinate initial IP shipment across regions
• Assist with aspects of CTMS set-up, and ensure relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Prepare for and attend Investigator meetings; may present materials as requested
• Assist CRAs in negotiating individual budgets and contracts with sites
• Coordinating legal review of any changes to the Clinical Trial Research Agreement (CTRA) document creation and maintenance
• Assist PM to develop the study plans, including but not limited to the Clinical Monitoring Plan (CMP) and update plans during the study
• Develop and distribute an annotated report template and template visits confirmation/follow-up letters in accordance with any Sponsor requirements.
• Maintain ICF version tracking and assist with ICF translation process if required
• Lead internal CRA meetings/teleconferences and may be required to prepare for the meeting, presenting a section of the agenda and follow-up with specific tasks. May assist with preparing the agenda, meeting minutes and distributing additional communication
• May attend sponsor meetings and contribute as required. May assist with preparing the agenda, meeting minutes and distributing additional communication
• Prepare site newsletters/emails to keep site staff informed of key communication
• Support the PM with vendor management, e.g. central laboratory, IVRS/IWRS providers
• Support the PM in ensuring CRAs are adequately trained on project specific requirements including study protocol, specific procedures, project plans, and related forms and the Case Report Form
• Support PM in developing and implementing subject recruitment strategies at the study and site level
• Assist with CTMS maintenance during the course of the project
• Review visit reports and site 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 and maintain protocol deviation tracking in CTMS
• Ensure appropriate issue escalation and tracking of these to resolution, proactive identification ofareas of risk and develop risk management strategies
• Oversee safety reporting processes to ensure in line with local and regional regulatory requirements
• Provide guidance to CRA team through mentoring and consistent communication.
• Oversee data collection and query resolution throughout the project
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• Assist PM with response to audit findings and assist CRAs with completion of any CAPA review and documentation
• Support PM with managing CRA resources to ensure monitoring activities are within budget and notifying the PM of any changes required or changes in scope
• Serve as back-up PM and back-up CRA as necessary during team absences
• May act as primary liaison with study site personnel, conducts the site visit as pre-study site selection visit, site initiation visit, monitoring visit and close-out visit. To ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines (section 5.18)
• Extensive travel may be required (more than 50%)

To succeed in this role, you must have good command of English.

Key Requirements:

• Master’s/ Bachelor’s degree in pharmacy, nurse, life sciences required effective leadership and organisation and communicated skills
• Five years as a CRA is required
• Ability to work proactively with challenging situations
• Willing to travel upcountry (expected to be 40%, short period of time)
• Audit and inspection experience is a plus
• High energy, self-starter, agile, patient, creative problem solver with a curing desire to make a difference and drive Thailand clinical research industry forward

This leading firm needs no further introduction and now is a good time to join their expanding team.

If you are driven, determined and want to take the next step in your career, this is the role for you. Great career progression opportunities wait the right person in this exciting Clinical Team Lead job.

Apply today or call 02-344-4828 or 064 669 1469 (K.Nichapat) to discuss this new opportunity.

Due to the high volume of applications, our team will only be in touch if your application is shortlisted.

Robert Walters Recruitment (Thailand) Limited
Recruitment License No.: น. 1188 / 2551