GSK
LDL(Oncology)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“LDL (Oncology) at GSK. Skills: clinical operations, study management, Oncology, GCP, ICH guidelines, local regulatory requirements, communication, leadership. Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of across all oncology areas (solid and blood) to the required quality standards, GSK written standards, local regulations and ICH GCP.. Leads the local study team cons”
What You'll Achieve.
Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local / regional regulations, IND/GCP/ICH-guidelines, GSK procedures.; Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit / inspection quality are met.; Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.; Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
Industry & Context.
Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.; Identifies and resolves or escalates issues and risks that may impact study delivery.
Available and willing to travel as job requires.
What They're Looking For.
Must Have
Bachelor’s degree in life sciences, pharmacy, or a related field., At least 3 years of experience in clinical operations or study management., R&D Experience and knowledge in Oncology areas., knowledge of GCP, ICH guidelines, and local regulatory requirements., Proven ability to manage complex clinical studies across multiple geographies., Excellent communication and leadership skills, with the ability to collaborate effectively., Fluency in Japanese and English. (Japanese: JLPT 1 level and English: TOEIC score of 800 or above is required. )
Nice to Have
Master’s degree in a science-related field., Advanced knowledge of drug development processes and clinical trial operations., Ability to lead cross-functional teams and manage external partnerships.
What You'll Do.
oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of across all oncology areas (solid and blood) to the required quality standards
GSK written standards
local regulations and ICH GCP.
Leads the local study team consisting of within-country clinical operations team members
cross-functional experts (clinical
vendor staff and external clinical site staff involved in study preparation and providing both matrix leadership and project management of study activities within the countr(ies).
Serves as the operational point-of-contact between the central GSK study team and within-countr(ies) study team.
Collaborates closely with local clinical
medical and regulatory affairs staff to align on local medical and scientific requirements.
Collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies).
Accountable for within-country delivery of assigned studies to time
budget and quality expectations as defined in the clinical development plan and study protocol as well as in local / regional regulations
IND/GCP/ICH-guidelines
Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets
patient recruitment cycle times
data and audit / inspection quality are met.
Provides trouble-shooting and problem resolution support for within-country study team to ensure productive
efficient study delivery.
Accountable for the accuracy of study systems
including completeness of the trial master file
and reporting study delivery progress to study team and key stakeholders.
Identifies and resolves or escalates issues and risks that may impact study delivery.
Provides feedback on performance
capabilities and competencies of local study members to line management.
Reviews and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
track and deliver against the local budget for the studies within their scope of responsibility.
Advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.
Prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs).
Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study.
Acquires and maintains an appropriate level of knowledge on the study compound
pathology of disease area being studied
competitive landscape within coutnr(ies)
local treatment/immunization guidelines and local health care system requirements.
Assists with audits/inspections of local clinical operations department and study / sites in the countr(ies).
Continuously develops knowledge in the areas of GCP
internal company guidelines
site and project management skills and capabilities.
Identify and share best practices.
How You'll Work.
Team & Collaboration
Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (clinical, biostats, medical, regulatory, supply logistics, finance, legal, etc. ), vendor staff and external clinical site staff involved in study preparation and providing both matrix leadership and project management of study activities within the countr(ies).; Serves as the operational point-of-contact between the central GSK study team and within-countr(ies) study team.; Collaborates closely with local clinical, biostats, medical and regulatory affairs staff to align on local medical and scientific requirements.; Collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies).; Provides feedback on performance, capabilities and competencies of local study members to line management.; Ability to lead cross-functional teams and manage external partnerships.
Communication Scope
Excellent communication and leadership skills; communication
Process & Methodology
project management of study activities, manage complex clinical studies across multiple geographies, project management skills
Full Job Description
_**Job Purpose**_ * Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries; across all oncology areas (solid and blood) to the required quality standards, GSK written standards, local regulations and ICH GCP. _**Key Responsibilities**_ * Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (clinical, biostats, medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project management of study activities within the countr(ies). * Serves as the operational point-of-contact between the central GSK study team and within-countr(ies) study team. The LDL collaborates closely with local clinical, biostats, medical and regulatory affairs staff to align on local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies). * Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local / regional regulations, IND/GCP/ICH-guidelines, GSK procedures. * Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit / inspection quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery. * Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders. * Identifies and resolves or escalates issues an
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