Site Name: Italy - Verona Posted Date: Sep 10 2024 The LDL provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country, across all therapy areas (Pharma and Vx) to the required quality standards, GSK written standards, local regulations and ICH GCP.
Job purpose and key responsibilities: Leads the local study team consisting of within-country clinical operations team members, liaising with 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 country.
Serves as the operational point-of-contact between the central GSK study team and within-country study team.
Collaborates with the local and above-country teams for conducting study feasibility and site selection within country.
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.
Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
Ensures that critical study timelines related to study activities within-country are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met.
Prepares the local Informed Consent Form and required submission documents and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA)/local Ethics Committees (ECs).
Maintains communication with the LOC Start Up Team 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 country, local treatment/immunization guidelines and local health care system requirements.
Why you?
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.
Experience in clinical development or equivalent experience in the pharmaceutical industry is required.
Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of RD and drug/vaccine development process.
Strong project management skills; comfortable projecting, managing, and reporting budget information (business and financial acumen) and able to develop scenarios and effective contingency plans.
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.
Preferred Qualifications: The following characteristics will be considered a plus: Masters of Science, PhD or equivalent coupled with previous project management experience.
Strong written and verbal communications skills are required in English and local language of the country.
Knowledge of local language (Italian).
Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment.
Able to set and manage priorities, resource and performance targets of local study deliverables.
Recognizes potential risks and can implement effective mitigation strategies.
Knowledge or ability to acquire expertise regarding use of multiple systems/tools related to clinical studies.
Closing Date for Applications – 30th September Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
#LI-Hybrid 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.
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