About this role: Global Study Director ~ Pharma (Hybrid)
We are currently hiring a Global Study Director (full-time, permanent) for our client. Our client is a global pharmaceutical company leading a revolution in oncology with one of the most diverse portfolios in the industry producing medicines and vaccines. The company has an inclusive culture that champions diversity, collaboration and is committed to lifelong learning, growth, and development.
The Global Study Associate Director, Biopharmaceuticals will be backed by leadership and empowered at every level to prioritize and make bold moves. The company’s pioneering approach is identifying and treating patients earlier, focusing on early-stage cancer trials and listening and evolving based on their needs. The successful incumbent will be joining a dedicated Biopharmaceuticals Research and Development team that is growing fast and building a strong track record of success.
- Lead and coordinate a team of experts in accordance with the study team operating model and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of timelines, budget and quality standards
- Contribute to vendor/external service provider selection activities at the study level, including bid defense, and lead operational oversight
- Assist the Senior Director Study Management with planning for upcoming clinical studies
- Collaborate with other functions to establish strategies and identify common practices aimed at increasing efficiency of global study teams
- Lead and facilitate communication across functions and provide guidance to study team members as needed
- For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study
- Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)
- Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
- Develop and maintain relevant study plans including required input into study level quality and risk management planning with risk response strategies and clear issue resolution pathways
- Oversee study level performance against agreed upon plans, timelines and key performance indicators (quality and operational) by using company tracking systems and project timelines, while communicating any risks to timelines and/or quality, along with proposed mitigations
- Identify and report quality issues that have occurred and collaborate with all functions as necessary to overcome barriers and achieve desired outcomes
- Oversee Trial Master File (TMF) completion including ensuring the TMF plan and Expected Document List are in place and that QC activities are performed on an ongoing basis
- Ensure timely compliance with company-wide governance controls
- Responsible for study budget re-forecasting following initial budget estimate provided by the Clinical Program Team and accountable for budget management through the study lifecycle
- Support professional development of team by providing regular feedback on individual performance
- Provide guidance, training, expertise, mentoring and support to less experienced study management colleagues
- Leads non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
- Collect and report Adverse Events in accordance with policies and procedures
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
- Previous global project management experience and training
- 5+ years of clinical trial experience
- 3+ years of experience in global study leadership and team leadership
- Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery; start up, maintenance and close out.
- Thorough understanding of the cross-functional clinical trial process
Skills & Capabilities
- Strong strategic and critical thinking abilities
- Proven skillset and abilities to solve complex problems and make strong decisions
- Strong abilities in establishing and maintaining effective working relationships with strong conflict management skills
- Demonstrated abilities in mentoring
- Excellent communication and interpersonal skills
- Ability to lead multiple challenging priorities
- Experience in external provider oversight and management
What We Offer
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How to apply
If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:
- Cover Letter (optional)