GSK Pharma Clinical Trial Manager (Local Delivery Lead)

Job description

Details:
Job Purpose:

The Local Delivery Lead (LDL) is the lead role for within-country operational feasibility, planning and delivery of Phase I-IV clinical trials and epidemiological and Health Outcome studies in a specific country or cluster of countries. They are accountable for within-country execution and 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. Their scope of work includes matrix leadership and project management of country and site-level activities including site management & monitoring activities within their assigned countries. The LDL serves as the operational point-of-contact between the central Study Delivery Lead and in-country operational staff aligned to study.
In all geographies it is recognized that the LDL is part of the local GSK community and collaborates closely with local medical staff (who are responsible for local medical and scientific elements of the study) as well as with Clinical Research Associates (CRA)/monitors and other in-country staff.

Key Responsibilities:

- Accountable for developing in-country study operational model and overall project management of study activities in a country for studies of simple to moderately high complexity based on experience; less experienced role holders may be expected to require a limited level of oversight in the conduct of some or all of these activities
o Accountable for execution/delivery of in-country components of clinical study to agreed timelines & budget; coordinates other in-country functions; takes operational decisions to ensure study delivery
o Ensures development and maintenance of country study plan and forecast, including detailed budgets, resource estimates, milestones, quality and risk planning
o Manages in-country study communications & issue escalation; communicates progress & escalates issues to the Study Delivery Lead and other functions as required
o Develops/manages the development of local aspects of key study documents, plans & manuals (e.g. study management and monitoring plan, study procedures manual, and core operational packages for submission and for countries; develops local recruitment and other site support materials as required
o Co-ordinates as necessary key local requirements including local informed consent form, ethics committee approvals, intercompany clinical trial agreement (iCTA), third party agreements & payments
o Selects & manages local vendors (if needed & with appropriate managerial support if required) in accord with local practices & in alignment with overall resourcing strategy for the study; accountable for CRO & vendor management including oversight, payments, communications & issue management
o Escalates resourcing issues to ensure that in-country study activities are appropriately resourced
- Accountable for local activities required in study design and set up (seeks managerial or other experienced support (e.g. Sr LDL) as appropriate)
o Contributes to the study concept and protocol, and co-ordinates other expert local input as required;
o Coordinates overall country feasibility (in priority pre-selected countries) and site feasibility
o Coordinates the activities of all other in-country operational staff to deliver study objectives and ensures appropriate training of in-country staff and investigator sites
o Leads selection of external clinical sites within country; is accountable for overall site performance
o Arranges accurate translations of key documentation into the local language as needed
o Ensures necessary supplies (vaccine product, non-vaccine supplies, other materials etc) are available at sites and manages local site supply activities as needed
- Accountable for high quality execution/delivery of studies within country/countries as defined by protocol & according to timelines/budget agreed with & set by SDL; will seek managerial/experienced support (Sr LDL) as necessary
o Ensures site readiness to initiate trial
o Tracks country delivery to time, cost and quality, including maintenance of standard tracking tools
o Ensures appropriate study oversight in-country: coordinates local internal & external operational activities; maintains clear visibility to clinical sites' progress, & issues at all times; reviews in-country protocol deviations; ensures appropriate issue escalation & follow-through within country/region and above country as needed; communicates status/issues effectively to central team through SDL; ensures monitoring plan is followed & monitor visit report review occurs within defined timeframes
o Serves as matrix manager of other local operational staff (CRA/monitors, other local support staff) deployed to assigned study; provides direction and establishes study-related objectives for other staff on matrix team; provides feedback to local Clinical operations management on staff study performance
o Ensures conduct of assigned studies in the country / countries according to all applicable regulations, ICH/GCP, GSK Corporate, Vaccines, and local POLs and SOPs;
o ensures implementation of in-country study-specific quality assessments (L1), inputs to site assessment/audit proposals and delivers country response& follow-up to assessment/audit reports
o Ensures development of country-level study risk assessment and mitigation plan
o Specifies and reviews local trial monitoring tools (TMTs), monitors key risk and performance indicators (KRIs and KPIs) and other reports as required
o Monitors country and site enrolment and takes corrective actions
o Accountable for Level 1 oversight of monitoring activities including co-monitoring as necessary to ensure full understanding of realities on site; escalates issues appropriately
o Regularly discusses progress, risks and issues with the Study Delivery Lead and communicates relevant information to local stakeholders as appropriate
o Ensures robust communication with sites, e.g. timely communication of protocol amendments
o Co-ordinates and delivers operational aspects of local study meetings (if not centrally co-ordinated) including investigator meetings, monitor meetings, local training and other local coordination meetings.
o Reviews and approves the Monitoring Visit Report
o Manages operational aspects of investigator and site relationships; ensures delivery of key study documentation to the sites; ensure contractual agreement with external parties; oversees accurate and appropriate payments/compensation of third parties including clinical investigator sites & institutions

Our Offer:

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.

Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.

Our Company:

GSK is a science-led global healthcare company with a mission to help people do more, feel better, live longer. At GSK, we research, manufacture and make available a broad range of medicines, vaccines and consumer healthcare products.

GSK Vaccines is a world's leading company, involved in vaccine research, development and production. We have 16 candidate vaccines in development and our broad portfolio of around 40 vaccines prevent illnesses such as hepatitis A, hepatitis B, diphtheria, tetanus, whooping cough, measles, mumps, rubella, polio, typhoid, influenza and bacterial meningitis. Globally, we have more than 16.000 people working to deliver vaccines safely, every day, to people in 90% of the world's countries. In 2014 we distributed around 800 million doses of vaccine, 80% of them to least developed, low and middle income countries.
For further information, please visit www.gsk.com.
GSK Consumer Healthcare produces a range of consumer health products based on scientific innovation. They develop and market a range of products in the areas of: Pain Relief, Respiratory, Oral Health, Nutrition/Gastro Intestinal and Skin Health. These include a number of well-known brands such as Sensodyne, Paradontax, Poligrip, Voltaren, Panadol, Otrivin and Theraflu.

GSK Pharmaceuticals includes research, development and manufacture of medicines for a variety of serious and chronic diseases. This includes market leading products for Respiratory, Anti-Viral, Central Nervous System, Cardiovascular and Urogenital, Anti-Bacterial, Oncology and HIV.

*LI-GSK

Contact information:
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Desired profile

Basic qualifications:
- 3-4 years of previous Clinical Operations experience with at least 2-3 years of in-country monitoring or study management experience or equivalent; .demonstrated high level of understanding of clinical research and clinical trial management, and the associated regulatory, processes and quality requirements.
- Strong knowledge / Experience in project management

Preferred qualifications:
- Given the interactions with multi-disciplinary teams and with external medical staff (including key external experts), proven experience in the domain is required.
- Given the nature of the job and accountabilities for local execution, strong project management skills are required to coordinate across all deliverables and lead local study teams to meet time, cost and quality requirements.