Global Clinical Development Associate Director
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Jun
Reporting to the Study Delivery Lead (Team) Director, this job within Global Clinical Delivery (GCD) combines end-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams.
This position within GCD is accountable for planning and leading the delivery of oncology 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 y career.These responsibilities include some of the following:
- Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc) and for overall study deliverables.
- Drive assessment, selection, engagement, management, and oversight of appropriate vendors.
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
- Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
- Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project allocation.
- Preparation of materials for governance and / or financial review cycles.
- Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
- Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
- Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary.
- Identify and communicate resource gaps for assigned studies.
- Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
- Lead / contribute to ways of working and process improvement initiatives.
- Provide expert clinical operational input into protocol development.
- Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study.
- Actively partner to build relationships and collaborate with Oncology aligned staff in other global functions e.g., partnering with functional lines to deliver the Clinical Study Report.
- Work with the Oncology patient councils to develop patient centric documents and address patient burden.
_ 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.
- Extensive clinical development experience with at least 6 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.
- Proven operational experience of leading high performing global study teams in Oncology clinical trials.
- Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget
- Excellent leadership skills, influencing and negotiation skills.
- Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.
- Indepth knowledge of either study management or data management and knowledge of essential global regulatory guidelines and ICH/GCP.
- Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and thirdparty vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
- Excellent project management skills and budget management skills.
- Possess competent written skills and experienced in authoring patient facing materials, study procedures manuals, pharmacy manuals, and informed consent forms.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Proven clinical development experience across all phases of development (I-IV).
- 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 decisionmaking where necessary and ability to manage conflict.
- Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting crossfunctional matrix teams.
- Creative thinker able to modernise approac
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