Local Delivery Lead

Il y a 4 mois

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre
**Posted Date**: Oct 1 2024
**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 therapy areas (Rx and Vx) 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 (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 mangement 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 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.

**Why You?**:
Basic qualifications:

- Bachelors degree or equivalent.
- Any general science degree e.g. life science, medicine, clinical research, pharmacy etc.
- Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field. A minimum of 3 years of clinical research experience within GSK or externally.
- Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives.
- Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process. Effective at problem solving, negotiation and conflict resolution skills in a matrix environment.
- Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.
- Strong written and verbal communications skills are required in English and local language of the countr(ies).
- Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and adapts to these changes quickly and efficiently.
- Demonstrates track record in

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