Associate Director, Study Delivery Lead

**Site Name**: Warsaw, Belgium-Wavre, India - Karnataka - Bengaluru, Italy - Siena

**Posted Date**: Apr 26 2023

This position within GCD is accountable end to end from CSI (Commit to Study Initiation/ Study Kick off meeting) 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.

**This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following**
- 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
- Accountable for assessment, selection and oversight of critical third party vendors (e.g. CROs, etc..)
- 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 company strategy to the study and Ensure appropriate stakeholder communication, including study status, expectations, risks and issues
- Accountable for the study budget
- Effectively build and lead empowered matrix teams
- Responsible for operational input into protocol and informed consent form development, and other key study documents
- Lead quality efforts to ensure study compliance and continual inspection readiness for assigned studies

**_ Why you?_**

**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- Master’s degree in life sciences or related discipline
- ** Extensive clinical development experience with at least 3 years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment**
- Fluent English
- Proven operational experience of leading high performing global study teams in clinical trials with ability to translate strategic concepts, stakeholder feedback and requirements into cohesive actions for the study team
- Excellent leadership skills, influencing and negotiation skills.
- In-depth knowledge of study management and essential global regulatory guidelines and ICH/GCP
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
- Experience of innovative trial design (platform, basket, umbrella, adaptive designs) and decentralised trials (DCT) initiatives.
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict

**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:

- Creative thinker able to modernize approach to clinical delivery, leverage external technology and networks to deliver value
- Ability to articulate and champion key decisions and strategy
- Ability to define value-driven vision and roadmap for the study
- Ability to effectively prioritize activities and stakeholder needs
- Makes timely and complex decisions based on strong rationale
- Ability to manage change

**_ Why GSK?_**:
**What we offer**:

- Performance with Choice - flexibility in working mode (hybrid between office and remote work based on employee needs)
- Contract of employment
- Flexible working hours
- Established job in an international, well-known pharmaceutical company
- Opportunity to work in professional team playing crucial role in introducing GSK portfolio to the market
- Opportunity to work within GSK standards and documentation applied globally
- Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, Company Car)
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement)
- Possibilities of development within the role and company’s structure
- Personalized learning approach (mentoring, online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
- Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
- Supportive community and integration events
- Modern office with creative rooms, fresh fruits every day

**CLOSING DATE 10th May 2023**

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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