Oncology Global Clinical Development Manager
il y a 1 semaine
Site Name:
Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Pennsylvania - Upper Providence, Warsaw, Wavre
Posted Date:
Mar
Global Clinical Development Manager
Remote working outside of listed locations may be considered for a limited number of qualified applicants by exception and where the needs of the individual and the business can both be met.
The Role:
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.
The role may span oncology assets from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models.
Key attributes include demonstrated ability to input to and influence studies/projects through operational expertise and effective stakeholder management. This job requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change.
Key Responsibilities:
- Lead the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc).
- Drive assessment, selection, engagement, and management 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.
- 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 the conduct of investigator meetings and other study related meetings.
- Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
- Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project budget allocation.
- Lead / contribute to ways of working and process improvement initiatives.
- Input into protocol development from a Clinical Operations perspective.
- 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.
- Considerable 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.
- 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.
- Strong leadership, 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 regulatory guidelines and ICH/GCP.
- Proven experience working with investigators, external experts and regulatory agencies and effective oversight of Contract research Organisations 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 and budget management skills; review vendor invoices and drive the tracking of spend against approved budget.
- 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 fol
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