Study Delivery Lead

il y a 3 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre, India - Karnataka - Bengaluru, Warsaw Zwirki Wigury

**Posted Date**: Apr 12 2023

The Study Delivery Lead (SDL) is the Project Manager of a study. As such, you are accountable to ensure end to end from CSI (Commit to Study Initiation) until study archiving for planning and leading the delivery of interventional, studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds.

**Your responsibilities**:

- accountability for the operational delivery of clinical study to time, quality, and budget (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc), driving decision-making at pace and leading study team to achieve overall study deliverables.
- Support assessment and selection of FSO vendors,
- Accountable for holistic oversight of FSO vendors according to the FSO handbook
- Accountable for assessment and selection of other study vendors under GCD responsibility.
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies. understand study contribution to program/submission
- Accountable for translating asset requirements to the study and appropriate communication with the Asset Lead
- Balance risk/benefit to make decisions based on clear understanding of impact on the study and project.
- Proactively and effectively identify, oversee and mitigate study risks.
- Ensure appropriate stakeholder communication, including study status, expectations, risks and issues
- Preparation of materials for governance and / or financial review cycles.
- Accountable for the study budget
- Effectively build and lead empowered matrix teams;
- Implement innovative approaches to study delivery through external facing advances in technology and sciences and encourage others within matrix and line teams to seek innovative perspectives and develop solutions. Decision maker for the innovative solutions (eg DCT, ) to be used at study level
- Responsible for operational input into protocol and informed consent form development, and other key study documents.
- Lead and conduct investigator meetings and other study related meetings; participate in governance meetings as required.
- Lead quality efforts to ensure study compliance and continual inspection readiness for assigned studies.
- Identify and communicate resource gaps for assigned studies.
- Lead / contribute to ways of working and process improvement initiatives

**_ Why you?_**

**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- Bachelor's degree in life sciences or related discipline
- At least 3 year experience in clinical research : study management, monitoring, data management
- Strong skills and experience in project management and tools In depth knowledge of GCPs and ICH guidelines
- Solid experience working in teams with a broad range of cultures, including team leadership
- Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
- Excellent understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
- Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)
- Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others
- Able to set and manage priorities, performance targets and project initiatives in a global environment
- Operational expertise in risk management and contingency planning
- Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency
- Demonstrates conceptual, analytical and strategic thinking
- Effective at problem solving and conflict resolution
- Ability to manage change and uncertainty
- Ability to delegate tasks

**Preferred qualifications**:

- If _you _have the following characteristics it would be a plus:_
- Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills. Knowledge of French an asset.

**_ Why GSK?_**:
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 billi

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