Local Delivery Lead (LDL)

• Expected Years of Experience in Role: 1-3 yrs

Job related skills -

• Demonstratesflexibility and resilience with the ability to evolve in an always changing and challenging (internal and external) environment processes and systems.
• Demonstratesexcellent leadership skills promoting motivation and high-quality performance of others toaccomplishindividual team and organizationalobjectives.
• Demonstratesan excellent understanding of clinicalstudy drug development sample management and other associated processes and quality requirements.
• Has a strong project management mindset anddemonstratedability to work and lead in a matrix team environment involving both internal (GSK) and external partners.
• Able torepresentGSK to external physician investigators and other external clinical site staff institutional review boards etc. including the ability to answer complex questions.
• Able to work effectively within the local environment and ifother regional environments and collaborate extensively with remote central team members. Ability to work effectively in a remote environment.
• Able to set and manage priorities and performance targets in a local environment and ifrequiredother regional environments.
• Effectively plans communicates coordinates andfacilitatesdelivery of local/regional teamobjectives.
• Demonstratesa solid understanding of country local regulations and if required basic understanding of othercountriesregulations ICH-GCP guidelines and GSK written standards.
• Available and willing to travel for project related activities asrequired(e.g. Investigator & Monitors Meeting attendance)
• Acts as role model in line with GSK culture including values and behaviors.
• Able to understand and apply new digital innovations to our clinical trials.
• Able todemonstrateconceptualanalyticaland strategic thinking including data literacy.
• Effective at problem solving and conflict resolution.
• Demonstratesgood English language written and verbal communication skills in addition to proven negotiation skills.
• Demonstratesflexibility with high learning agility.
• Demonstratesstrong computer skills and the ability and willingness to learn and master new or evolving computer systems to support business requirements effectively.

Job Responsibilities

• Leads the local study team consisting of within-country clinical operations team memberscrossfunctionalexperts (medical regulatory supplylogistics 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 country(ies).
• Serves as the operational point-of-contact between the central GSK study team and within-country(ies) study team. The LDL collaborates closely with local medical and regulatory affairs staff to align local medical and scientific requirements. As required collaborates with the local and above-country teams for conducting study feasibility and site selection within country(ies). Leads selection of sites within country(ies) and is accountable for local study performance. 13
• Accountable for within-country delivery of assigned studies to timebudgetand 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 quality and integrity of clinical studies by taking onappropriate businessmanagement monitoring activities.
• Ensures development maintenance of country study plan and that critical study timelines related to study activities within-country(ies) are accurately forecasted and achieved including budgets resource estimates milestones timelines quality and risk planning and that recruitment targets patient recruitment cycle times data and audit / inspection quality are met. Provides troubleshooting and problem resolution support for within-country studyteamto ensure productive efficient study delivery. Ensures necessary supplies are available at sites and manages local supply inventory.
• 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 and to specify and reviewincountrystudy monitoring tracking toolsmonitorskey risk and performance indicators and other reports. Review all study databases to ensure 100% accuracy.
• Ensures development of country / site-level risk assessment to proactivelyidentifyrisks develop a mitigation plan and to escalate issues and risks that mayimpactstudy delivery.
• Will review and approve monitoring visit reports and ensureappropriate sitemonitoring activities have been completed per the study monitoring plan. May provide feedback on performance capabilities and competencies of local study members to line management.
• Has theaccountabilityto create and manage study budgets (budget updates expenditures including site payments across a study) and estimate track and deliver against the local budget for the studies within their scope of responsibility. As required advises support / develops andnegotiates oncontract development with Sites/CRO/Vendors ensuring legal input whereand mayparticipatein budget/contract negotiations with study vendors or clinical investigator sites. As required selects & manages local vendorsin accordance withlocal practices & in alignment with overall resourcing strategy for the study; accountable for local vendor management including oversight agreements payments communications & issue management.
• Manages the development of key study documents plans & manuals according to local requirements (monitoring plan local informed consent form import/export licenses etc.). May provide input into the study concept protocollogisticsand may co-ordinate other expert local input. As requiredmayarrangeaccuratetranslations of key study documentation intolocallanguage.
• As requiredpreparesthe local Informed ConsentFormandcoordinatesthe 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 metin a timely mannerthroughout the study.May also be accountable for Regulatory Authority submissions and approvals.
• Acquiresandmaintainsan appropriate levelof knowledge on the study compound protocol pathology of disease area being studied competitive landscape within country(ies) local treatment/immunization guidelines and local health care system requirement as well as study protocol training and all study related activities. Participate continuously in relevant training courses to improve personal/professional skills.
• As requiredassistswith audits/inspections of local clinical operations department and study / sites in the country(ies). May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response &followupto assessment/audit reports.
• Continuously develops and keeps up to date knowledge in the areas of GCP internal company guidelines SOPs new monitoring site and project management skills and capabilities. Responsibleto identifyandbest practices.
• Available and willing to travel as job requires.
• Ensuresappropriate trainingof in-country staff and investigator sites; coordinates & delivers operational aspects at local study meetings including investigator meetingsmonitormeetings and local training.
• Escalates resourcing issues to ensure that in-country study activities are appropriately resourced.
• Ensures robust communication and engagement with sites e.g.timelycommunication of protocol amendments.
• Reviews and approves Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status.
• Ensures ongoing management and reporting of study specific safety issues and safety report handling asrequired(including SAE reporting).
• Co-ordinates / contributes to end of study / program learning debriefs andidentifyareas for improvement.
• Interact and collaborate with GSK Country study staff and staff from other functions as needed (e.g. Medical legal finance etc.)
• Communicate and work effectively with medical staff/physicians/scientists who are often senior within their field being mindful of their standing within the medical and/or research community.
• Interactions with key partners including ethics boards pharmacies vendors.