Local Delivery Lead

Site Name: Warsaw, Poznan Posted Date: Jul 20 2022 Local Delivery Lead 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. In a senior capacity, will lead a portfolio of studies within-country or cluster of countries and act as a role model, coach, mentor for less experienced LDLs on processes, technical and behavioural competencies. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Why you? 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 management of study activities within the countr(ies). Accountable for within-countr(ies) 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 regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs. 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 quality are met. 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. Takes a leadership role in identifying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level. Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility. 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. Available and willing to travel as job requires. (approx. 15%) Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 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’ experience in clinical operations is required. 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 Strong written and verbal communications skills are required in English and local language of the countr(ies). Strong project management skills; comfortable projecting, managing, and reporting budget information (business and financial acumen) and able to develop scenarios and effective contingency plans. Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies. At GSK we offer a wide range of additional benefits: Career at one of the leading global healthcare companies. Contract of employment. Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit). Life insurance and pension plan. Private medical package with additional preventive healthcare services for employees and their eligible. Sports cards (Multisport). Possibilities of development within the role and company’s structure. Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training). Extensive support of work life balance (possibility of working from home, flexible working solutions, short Fridays option, health & well-being activities). Supportive community and integration events. 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