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Local Delivery Lead (LDL) Nordic Cluster
As GSK continues to invest in clinical studies they are now looking for someone with Nordic experience from clinical research who wants to be part of the company´s further development of the clinical study team. Take this opportunity to be part of this great clinical study team at GSK as they strengthen the team with a Nordic position – Local Delivery Lead (Local Study Manager), Nordic Cluster.
This position provides matrix leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in the Nordics; across all therapy areas (pharma and vaccines) to the required quality standards, GSK written standards, local regulations and ICH GCP. The position is based at the Solna office and you will report to the Local Delivery Lead Manager Nordic Cluster.
Job purpose and 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-country 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 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.
- 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 escalate risks and issues that may impact study delivery.
- Provides feedback on performance, capabilities and competencies of 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 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.
- As required, assists with audits/inspections of local clinical operations department & study / sites in the country.
- 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.
Who are you?
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. Preferably Masters of Science, PhD or equivalent coupled with previous project management experience.
- Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field. A minimum of 3 years of clinical research experience, from a Nordic perspective.
- Experience within oncology is preferred but not required.
- Strong project management skills; comfortable projecting, managing, and reporting budget information (business and financial acumen) and able to develop scenarios and effective contingency plans.
- Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives.
- Strong written and verbal communications skills are required in English and Swedish.
In this recruitment GSK partner with Scientific Solutions and all questions and applications will be managed by Scientific Solutions.
To apply for this position, send in your CV and a short personal letter by email to email@example.com
Apply no later than August 15th 2021.
For further questions regarding the position, please contact us:
Anna Arnebrant, 073-995 56 25, firstname.lastname@example.org (unavailable during July 12th until 6th of August due to annual leave)
Yllka Rama, 076-264 75 69, email@example.com
Scientific Solutions specialises in talent supply for Life Science companies. We focus on management and specialist roles mainly within R&D, Clinical, Regulatory, Drug Safety, Sales and Marketing. www.scientificsolutions.se