Local Delivery Lead - Verona, Italia - GSK

GSK
GSK
Azienda verificata
Verona, Italia

1 mese fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee
Descrizione

Site Name:
Italy - Verona


Posted Date:
Mar


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 (Pharma 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.


_ Job purpose and key responsibilities:_

  • Leads the local study team consisting of withincountry clinical operations team members, liaising with crossfunctional 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 pointofcontact between the central GSK study team and withincountr(ies) study team. Collaborates with the local and abovecountry teams for conducting study feasibility and site selection within countr(ies).
  • Accountable for withincountr(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/ICHguidelines, GSK Corporate, Vaccines, and local SOPS and POLs.
  • Ensures that critical study timelines related to study activities withincountr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides troubleshooting and problem resolution support for withincountry study team to ensure productive, efficient study delivery.
  • Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
  • 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 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 coutnr(ies), 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.
  • Broad experience in clinical development or equivalent experience in the pharmaceutical. A minimum of 3 years' experience in clinical operations is required.
  • 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 (startup, recruitment and close out) and understanding of R&D 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 countr(ies).
  • 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.
  • Knowledge of local language (Italian).


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.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world
Altri lavori da GSK
Vedi tutte le offerte di lavoro di GSK