Director, Clinical Operations Project Management

The Director, Clinical Operations Project Management serves as 'chief of staff' to the VP, Global Clinical Operations and providing PM support in aligning strategy, creating accurate plans/forecasts, documentation, and coordinated execution across all Clinical Operations. The Director, Clinical Operations Project Management supports Clinical Operations team members in the development of clinical operations standards, study timelines, facilitates organizational alignment and seamless execution of studies/projects. This full-time, exempt position is based remotely, and reports directly to the Vice President, Global Clinical Operation.

The Director will interface within clinical operations and with cross-functional departments in particular Regulatory, Finance, Program Management, Clinical Affairs, Clinical Research Science, Technical and Supply Chain teams to facilitate creation of processes, procedures and other projects as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Management of Clinical Operations Budget/Contracts, Data Management and PM activities.
• Influence other corporate teams, clinical research organizations and consultants as needed
• Ensure compliance with all applicable internal policies and procedures, GCPs, and all applicable regulations; ensure inspection readiness of all regulated activities
• Ensure activities comply with the applicable Novocure Quality System requirements
• Guides the Clinical Operations team to enable efficient and high quality execution of global clinical studies
• Manages the development, maintenance, tracking, and management of operational plans
• Develops or coordinates the preparation of project reports and/or summaries on trial/project status
• Interacts with functional managers and business leaders to communicate critical project risks, questions or challenges
• Leads the overall internal and external communications of Clinical Operations. Proactively identifies and helps resolve issues to ensure smooth alignment of teams
• Influences the department in objective setting, prioritization and tracking, collaborates with internal and external stakeholders to identify key department issues
• May manage/support external vendors
• Lead or participate in initiatives and/or special projects, as assigned
• Proactively identifies and helps resolve issues to ensure smooth day-to-day operations and alignment of teams.
• Facilitates team interaction and team building striving for a high performing team.
  
  
  
  • Assist in the overall internal and external communications of Clinical Operations
  • Coordinates clinical operations or project objective setting, prioritization and tracking, collaborates with teams to identify key program issues.
  • May lead or participate in ad-hoc cross-functional sub-teams and task forces to address and resolve issues
  • Contributes to risk assessment and contingency planning and communicates status with the respective stakeholders in a transparent and timely manner
  
  
  
  
• Partners with the VP, Global Clinical Operations in preparation of comprehensive study recommendations, board meeting presentations and updates for governance boards

QUALIFICATIONS/KNOWLEDGE:

• Bachelor's Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable
• Minimum 10 years experience in pharma/medical device industry of which 5 years PM experience.
• Experience in clinical trials
• Strong project management experience. PMP, Six Sigma or similar professional project management certification is a plus
• Demonstrated leadership skills, especially in areas of communication and change management
• Meticulous attention to detail in all aspects of work and expert organization skills
• Proven ability to drive decision making process, including ability to challenge teams and achieve excellence
• Ability to thrive in a fast-paced environment
• Have a strong understanding of activities, associated budget, and key contributing factors in order to anticipate potential risks and establish plan to mitigate, as appropriate.
• Lead and facilitate regular internal clinical operations & cross-functional/cross-regional team meetings; ensure agendas and team priorities are clear, meetings minutes are distributed, action items are completed.
• Assist with issue resolution meetings; risk identification, prioritization and mitigation planning processes across the studies/department.
• Strong Self-Starter and hardworking individual who is used to working quite independently
• Proficiency in the following: Microsoft Office (Project, Word, PowerPoint, Excel, Access, EndNote, database search knowledge) and Google Business Solutions
• Exceptional written and verbal communication skills, including customer service skills and the ability to clearly communicate business processes and solutions in person and over the phone
• Familiarity with regulatory processes is a plus
• Effective and flexible to adapt and work in a fast paced environment and within cross-functional teams
• Exceptional organizational skills with the ability to manage and prioritize among multiple work streams
• Proficiency in the following: Microsoft Office (Word, PowerPoint, Excel, Access, EndNote, database search knowledge) and Google Business Solutions.
• Exceptional written and verbal communication skills, including customer service skills and the ability to clearly communicate business processes and solutions in person and over the phone
• Familiarity with regulatory processes is a plus

OTHER:

• Ability to lift up to 20 pounds

Equal Opportunity Employer, including disability/veterans

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

- innovation

- focus

- drive

- courage

- trust

- empathy