Global Study Director FSP EMEA

Work Schedule

Environmental Conditions

Job Description

Join Us as an Global Study Director - Make an Impact at the Forefront of Innovation
The Global Study Director (GSD) is a business-critical role within Cell Therapy Clinical Operations (CTCO) whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program that are deemed most critical to the business. The GSD 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 GSD may provide input to early study planning activities based on operational expertise. The GSD is accountable to the CPT for the delivery of a study or studies according to agreed upon timelines budget and quality standards by ensuring an effective partnership and teamwork within the study team. The GSD will also interface with other internal stakeholders cross-functionally and/or external partners to identify manage and resolve issues affecting study delivery.

The GSD leads the study team(s) and/or study oversight team(s) in accordance with the Study Team Operating Model for Internal Delivery (SOLID) Project Management Framework and/or clinical outsourcing model current clinical trial regulations (e.g. ICH GCP) Standard Operating Procedures (SOPs) policies and best practices and in line with our values and behaviours.

The GSD is also responsible for providing expert guidance direction mentoring and support to Global Study Managers on their studies for study specific activities.

What Youll Do:

• Lead and coordinate a cross-functional study team of experts in accordance with SOLID and its roles accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines budget and quality standards.
• Contribute to vendor/ESP selection activities at the study level including bid defense and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection.
• Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended).
• Lead and facilitate communication across 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 sponsor point of contact for the CRO Study Manager to ensurestudy 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 in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations).
• 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)) in accordance with relevant SOPs.
• Ensure all external service providers (i.e. central laboratories IXRS ePRO etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities.
• Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management proactive risk and contingency plans etc.) 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 (KPIs quality and operational) 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.
• Providing expert guidance direction mentoring and support to Global Study Managers on their studies for study specific activities.
• Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT quality assurance staff functional line management etc.).
• 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 financial attestations Clinical Trial Transparency).
• Responsible for study budget re-forecasting following initial budget estimate provided by the CPTand 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 (as part of the ongoing study change control process).

• Ensure studies are inspection-ready at all times according to ICH-GCP and SOP and relevant policies/guidelines. GSD is the primary CTCO Clinical Operations point-of- contact in the event of an audit or inspection.

• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development.

• Provide guidance training expert input mentoring and support to less experienced GSL colleagues on an ongoing basis.

• Leads non-drug project work such as CTCO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

Education & Experience Requirements:
University degree (or equivalent) preferably in medical or biological sciences or discipline associated with clinical research

Proven project management experience and training

At least 10 years of clinical trial experience

At least 5 years of experience in global study leadership and team leadership

Demonstrated clinical trial expertise in Oncology

Years of experience refers to typical years of related experience needed to gain the required knowledge skills and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge Skills Abilities:
Comprehensive therapeutic area knowledge clinical development guidelines and directives and regulatory guidelines
Expert knowledge of the key principles of cross functional project management (Time Quality Cost)
Excellent oral and written communication and presentation skills
Demonstrated leadership and interpersonal skills including the ability to lead motivate and coordinate cross-functional project teams
Technical and systems competency such as computer skills to include effective use of systems and applications such as Microsoft Outlook Word Excel and PowerPoint as well as organization systems (CTMS Preclarus Clarity)
Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment
Skilled in process improvement and strategic development especially as it applies to clinical trials clinical development and project management
Ability to coach mentor and lead global and/or cross-functional teams with a cultural awareness
Strong financial acumen with an in-depth of knowledge and practical application of budgeting forecasting and resource management.
Project Lead
Excellent customer service consultation and relationship building skills
Advanced negotiation and marketing skills with ability to influence others and drive results
Excellent judgment decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations
Proactive solutions oriented and skilled at risk identification and management.
Project Oversight
Excellent customer service and relationship building skills with the ability to proactively address and prioritize expectations
Strong executive presence and business acumen
Advanced negotiation and marketing skills with ability to influence others and drive results
Proactive solutions oriented and skilled at risk management
Excellent judgment decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations
Ability to drive corporate strategies to capture engage and retain repeat customers People Manager
Ability to identify and address training gaps for soft skill and technical development including managing performance stewardship metrics and retention
Excellent judgment decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to drive development and retention of top performers
Proven ability to act as a change champion
Ability to collaborate and foster accountability in a learning environment
Ability to drive process improvement and strategic initiatives
Strong negotiation skills with ability to influence others and drive results.

Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear garments and gloves.

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.