Clinical Trial Manager- FSP

Key Role and Responsibilities Summary

Trial Preparation

Accountable for the trial activities for responsible R/OPU, including but not limited to: 

• Ensure the trial is conducted in compliance with GCP-ICH, local/global regulations, applicable Standard Operating Procedures (‘SOPs’) and according to the trial protocol by overseeing CRO and internal team activities. 

• Creation, management and review of the R/OPU trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes. 

• Appropriate trial-specific training of R/OPU internal and external partners is performed in line with Trial Training Plan. 

• Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to ensure trial team members are aligned and on track.  

• Verifies and provides input into the country and site level feasibility and OPU commitment (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e. Medical Affairs, vendors if applicable).  

• Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value. 

• Frontloading of activities where possible at the R/OPU level to facilitate efficiencies as well as to ensure and leverage speed.   

• Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance.  

• Ensure timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders. 

Trial Conduct

• Maintains oversight during clinical trial conduct including adherence to Good Clinical Practice (GCP) and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.  In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, and safety reporting. 

• Monitor progress of patient recruitment endpoints and proactively update and action contingencies throughout trial conduct. 

• Support CTL during investigator meetings. 

• Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst Clinical Development & Operations (CD&O) and appropriate functions (i.e. Medical Affairs, Market Access, Patient Advocacy Relations (PAR) on regional/ local level. 

• Active participation in the CD&O community with a special focus on participating in the CTM network, to actively contribute to functional excellence. 

Trial Closeout and Reporting

• Ensures timely cleaning and delivery of clinical trial data.  

• Responsible for timely, complete and compliant archiving of all relevant R/OPU documents in the TMF, including all required documents from vendors. 

• Ensures timely submission of the Clinical Trial Report to Regulatory Authority/Ethics Committee and other external stakeholders as required by local regulations. 

• Shares information on trial results with Investigational sites and, if applicable, Patients (e.g. lay summaries). 

General accountabilities

• Build and maintain engagement with Investigators, other site staff and Patient Organizations (POs), in collaboration with other functions, to ensure trial speed and effective start up, conduct and close out. 

• Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions (i.e. Medical Affairs, Market Access, PAR) on regional/ local level. 

• Supports CTL to ensure issues are raised to Evidence team for timely action or mitigation. 

Leadership Competencies

• Creates an environment that inspires, motivates, and empowers colleagues and promotes one common CD&O identity, contributing to acceleration of clinical development timelines and value creation for patients. 

• Fosters a learning culture in CD&O regions by encouraging continuous learning, sharing best practices, and learning from failures. 

• Embraces innovative approaches and technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and one common CD&O identity. 

Regulatory and / or Organizational Requirements:

Ensures all tasks are carried out in accordance with respective applicable client SOPs, Business Practices, How To Guides (‘HTGs’) and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality, in accordance with client Values and a focus on speed and patient value. 

Job Complexity:

• Functionally leads local/regional trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted and reported in line with regulatory requirements. Requires orchestration of local/regional trial team, setting priorities, and integration with other functions as necessary throughout planning, conduct and closeout of trial. This requires co-ordination of/with diverse and international trial team members, and collaboration with other external stakeholders. The complexity of the role is driven by the strict regulatory and ethical requirements. 

• Works on global clinical trials with multidisciplinary, international teams and with internal and external stakeholders including suppliers and investigational sites. 

• Represents client at internal and external meetings, e.g. with investigational sites, patient organizations and/or regulatory agencies/inspectors. 

• Critical contribution to speed and value of client's clinical trials by providing input in strategic feasibility, maintaining relationship with sites and by implementing new innovative methods including digital innovations related to trial delivery. 

Interfaces:

Functional lead and/or project manager of local/regional trial team members and colleagues including but not limited to: 

• CD&O. 

• Other medical functions. 

• Local/ regional HP functions (including patient advocacy). 

• CRO and other suppliers. 

• Investigator and site staff. 

• Research networks. 

• Patient organizations (PO). 

Job Expertise:

• Strong clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams. 

• Experience in Therapeutic Areas relevant in client pipeline is desirable. 

• Understanding of local/regional major regulations. 

• Familiarity with guidelines and standard of care is desirable. 

• Experienced in working with CROs and POs is desirable. 

• Ability to build and maintain strong relationships of mutual value. 

• Excellent influencing and communication skills. 

Job Impact:

• Accelerates the delivery of innovative new therapies while bringing the best trial experience to sites and patients. 

• Clinical development of a substance occurs within Medicine Excellence KPIs, quality and budget given by Innovative Unit (‘IU’) and Human Pharma Business Unit (‘HPBU’). 

• Client sponsored trials conducted according to applicable regulations and client SOPs/procedures safeguard patient safety / well-being, and data quality and integrity. 

• Risk management at local/regional level allowing development of a substance in line with client strategy 

• Strong accountability to support local/regional trial oversight. 

Minimum Education/Degree Requirements:

Requires a university degree (e.g. Masters degree or comparable degree) with several years relevant experience in required area. Major focus: Biomedical Life Sciences. 

Required Capabilities (Skills, Experience, Competencies):

Strong Communication Skills: Demonstrates Accountability, Agility and Intrapreneurship (‘AAI’) approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness. 

Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors. 

Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently setting direction for teams. Demonstrates leadership behaviours of supporting, connecting and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common goal. Executes activities with a clear aim to deliver value to patients. 

Strategic Mindset: Strategic and visionary thinker who is future focused, creative, courageous and able to navigate through ambiguity. Integrates study strategy with overall Therapeutic Area portfolio. Embraces cross functional initiatives, applying innovative learnings. Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions. 

Coordination and Oversight: Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources. 

Project Management: Plans effectively, setting priorities, and defining actions. Makes effective use of resources and proactively strives for transparency and clarity to accomplish the business deliverables. Translates complex situations to actionable parts.  Anticipates and resolves challenges and translates learnings to new projects. Takes smart risks.