Local Delivery Lead (RWE)

Local Delivery Lead (Non-Oncology)

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 therapy areas (Rx and Vx) 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 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 and risks that may impact study delivery.
• If needed may provides feedback on performance capabilities and competencies of local study members to line management. As required will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
• Has the accountability to estimate track and deliver against the local budget for the studies within their scope of responsibility.
• As required advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.
• As required 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 protocol pathology of disease area being studied competitive landscape within coutnr(ies) local treatment/immunization guidelines and local health care system requirements.
• As required 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 SOPs new monitoring site and project management skills and capabilities. Responsible to identify and share best practices
• Available and willing to travel as job requires.

Basic Qualification

• At least 5 years of experience in clinical operations or study management
• Experience supervising external partners (e.g. CROs) across project delivery and compliance
• Strong knowledge of GCP ICH guidelines and local regulatory requirements.
• Excellent communication and leadership skills with the ability to collaborate effectively.
• Fluency in Japanese and English. (TOEIC score of 800 or above is required.)
• Knowledge and experience in the clinical trials/real-world evidence studies in the Japan market.

Education/certification/Language

• Bachelors degree in life sciences pharmacy or a related field

Preferred Qualification

Experience

• Proven ability to manage complex clinical studies across multiple geographies.
• Advanced knowledge of drug development processes and clinical trial operations.
• Experience collaborating with global organizations
• Experience in R&D and medical functions

Skill

• Project management certification

Education/certification/Language

• Advance degree in a science-related field.

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities contact . Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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