Medical Information Lead
Responsible for managing multiple operational deliverables across all service lines of varying scope size and indication within Medical Information Operations. Recognized as specialist in one or more areas across Medical Information Services. Actively contribute to global Medical Information process initiatives and work in close collaboration with Medical Information Management (LSM) customer delivery management team and Medical Information Infrastructure regarding project/client initiatives.
- Provide leadership in the implementation of service operational initiatives; system requirements; client requests and electronic reporting.
- Provide technical and functional expertise across Medical Information Services. Demonstrate a thorough understanding of various project protocol, therapeutic indications, budget and scope of work (SOW) across a myriad of projects; provide expertise and guidance in set up and maintain project files, standards, templates, electronic forums, databases and workflow.
- Provide historical perspective and input on client and process in collaboration with LSM. Communicate the successes or failures of previous initiatives and appropriately field concerns to customer delivery team and manager.
- Provide leadership to teams working in a matrix environment and coaching to junior staff.
- Promote sharing of ideas within teams to improve process efficiencies. Follow through effectively on actioned implementations.
- Ensure team is following standard best-in-class practices established by Lifecycle Safety Infrastructure.
- Establish ongoing and effective operational communications with LSM to ensure MI is providing high quality deliverables and meeting client expectations and to discuss general project status, milestones, Scope of Work, project issues etc.
- Work with LSM constructively in a matrix framework to achieve project and customer deliverables; proactively identifying issues and proposing solutions, providing them with technical support, functional expertise, identifying SOW changes and potential change orders, delegating client requests and implementation of new initiatives.
- Ensure financial project performance through oversight of key performance metrics (revenue, direct costs, time-sheet costs, utilization, and realization).
- Work with Medical Information LSM constructively in a matrix framework to achieve project and customer deliverables.
- Successfully implement and drive process initiatives, provide corresponding metrics to illustrate the productivity/profitability of new initiatives. Communicate confidently to the logistics and practicality of new processes.
- Ensure that a positive, collaborative team environment with project team members is maintained, encourage, motivate and lead by example, provide training and mentoring for project team members, customer delivery and operations staff, oversee allocation of team and project resource.
- Collaborate with operational team and managers to resolve performance related; staff efficiency; morale issues within teams.
- Ensure staff are trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practice (GCPs), FDA and ICH guidelines and regulations, Working Instructions and project instructions.
- Implement and support service operational decisions as determined and instructed by senior management.
- Participate in training across Medical Information service offerings. Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies.
- Lead team to achieving departmental goals e.g. Utilization; realization and productivity metrics.
- Drive continuous process improvements.
- Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Extensive knowledge of Lifecycle Safety processes audit practices, governing safety legislation/regulation; willingness to increase knowledge across Medical Information service lines and develop new skills.
- Extensive knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Quintiles SOPs, in depth knowledge and understanding of Medical Information processes; willingness to increase knowledge across Medical Information service lines and develop new skills.
- Strong organizational skills and attention to quality compliance.
- Self-motivated driven and ability to work autonomously.
- Excellent presentation and customer-focused skills.
- Excellent mentoring and coaching skills.
- Strong project management and leadership skills.
- Excellent judgment, decision-making and problem solving skills.
- Encourage a flexible and receptive approach to changing demands.
- Demonstrate strong cooperative relationship with team and LSM.
- Excellent written and verbal communication skills, effective report writing skills.
- Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree or educational equivalent in health science or other directly related field and 6 years’ clinical research experience in a Contract Research Organization or Pharmaceutical company including 4 years of LS (Pharmacovigilance, CEVA, Medical Information, Lifecycle Safety, Safety Publishing, Risk Management etc) experience or equivalent combination of education, training or experience.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- Will require occasional travel.
EEO Minorities/Females/Protected Veterans/Disabled
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