Job title:
Local Delivery Lead
Company
GlaxoSmithKline
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 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 quality decision-making and problem resolution. Able to set and manage priorities, resource and performance targets of local study deliverables. Recognizes potential risks and can implement effective mitigation strategies.
- Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.
- 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.
- Deep knowledge of human research regulations in the countr(ies), IND/GCP/ICH-guidelines and GSK SOP/POL/guidelines.
Preferred Qualifications:
- Masters of Science, PhD or equivalent coupled with previous project management experience.
#LI-GSKIf you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Expected salary
Location
Waver, Waals Brabant
Job date
Thu, 03 Oct 2024 02:49:09 GMT
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