Overview

• To provide management oversight/leadership to the Clinical Operations group for all Phase I-IV studies at SKLSI.
• Assure implementation of consistent and complaint clinical trial processes for all SKLSI clinical studies.

Responsibilities

• Play leadership role in a matrixed multi-disciplinary team (CMC, Drug Supply, Regulatory, Pharmacovigilance, Clinical, PM, Legal, Medical, QA, Compliance, Medical Affairs, and SKBP) in the design, start-up, conduct and closure of assigned clinical studies, including co-development Alliance partners.

• With the assistance of project management and finance responsible for entire Clinical Operations study budgets.
• Responsibility for clinical trial budgets for all Phase 1-4 trials, while reviewing synergies across vendors and budgets with the complexity of being able to invoice our partners for services required to meet health authority requirements.
• Accountable for representing and escalating issues related to Clinical Operations on resourcing, budget, and timelines for all studies conducted at SKLSI and communicating with appropriate stakeholders.
• Responsible for organizational effectiveness and personnel development for entire Clin Ops group, organizing trainings, sharing best practices and industry guidance/developments/trends.
• Oversight of all CRO interactions and manage vendors required for trial conduct either through the CRO or SKLSI directly and reviewing vendor capabilities to add value to current SKLSI processes for overall efficiencies and ensuring Sponsor oversight.
• May chair study team meetings with vendor and internal team meetings and drive vendor relationship management, investigate opportunities for new clinical trial vendors and execute CDAs, arrange capability presentations and provide the necessary follow up and recommendations.
• Provide oversight with SMEs for design and finalization of clinical study protocols, and production of relevant clinical trial analyses including first impressionable results, interim analyses, CSR and ensure global consistency.
• Provide input into development of study regulatory documents including health authority/IRB,CEC responses, DSUR, annual reports etc.
• Provide review and coordinate review of function experts and participate in due diligence activities in evaluation of early development products for all of Clin Ops.
• Ensure global and local clinical studies are executed, in adherence to GCPs, appropriate SOPs, and relevant regulations including FDA regulations/EU Directive and ICH guidelines and ensuring quality measures implemented.
• Develop best practices and lessons learned mechanisms.
• Work in collaboration with QA to develop and implement quality activities across all clinical studies.
• Provide direct management to entire Clinical Operations group which may include clinical trial associates, clinical trial managers, senior clinical trial managers, associate directors and directors.

Qualifications

• Variable; MS or PhD in relevant science
• 15 years of experience with combination of operational expertise and experience in data collection and evaluation. Good scientific writing skillsAbility to multitask
• Adapts to change
• Maintain composure under pressure
• Lead a department and motivate team
• Ability to follow verbal or written instructions and use of effective verbal communications
• Adapts change, adjust change and grasps information quickly
• Examine and observe details
• Assume a leadership role
• Interpersonal skills