Business Development, Clinical Operations
OSM Pharma are working with a leading Global Pharmaceutical company in Germany who are looking for Global Study Leader (GSL) is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. The GSL is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSL is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.
- Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
- Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
- For outsourced studies, be the primary AZ point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
- Provide input 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 engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
- Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
- Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
- Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
- Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
- Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
- The GSL is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
- Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines;
- Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
- Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;
- At least 6 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience (PMP certification is desirable but not mandatory). Experience on a global level is desirable'
- Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
- Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
- Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
- Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience. If you know someone who would be a great fit, please share this posting with them.