PURPOSE Apply knowledge and expertise including complex decision making activities to review, assess and process Lifecycle Safety
data
and information across all service lines. Recognized as specialist in
one or more areas. Provide oversight on small to medium service
operational projects and act as mentor to junior members of staff.
RESPONSIBILITIES
Receive, triage, review and process Lifecycle safety operational
data from various sources on time, within budget and quality standards. Perform
data entry for tracking and Lifecycle safety
databases,
coding relevant medical terminology, writing descript narratives,
generating queries pertinent to the case, performing quality control,
assisting with reconciliation, driving case closure, coordinating
translations and ensuring reports are sent to the customer within
assigned deadlines. Pre-process material for endpoint committee or core
laboratory adjudication. Preparation of material for submission.
Assess Lifecycle safety
data
for report ability to relevant authorities, track reportable cases and
report to regulatory authorities, ethics committees, institutional
review boards, investigators, oversight groups per legislation, within
timelines and in a format compatible to requirement. Liaise with local
Quintiles offices to facilitate expedited reporting. Liaise with systems
manager for regulatory tracking requirements and electronic reporting.
Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk
Management, Safety Surveillance and Medical Information or other service lines as appropriate.
Receive and document incoming telephone calls, faxes or emails from
investigative sites or other sources reporting operational
data.
Process Lifecycle safety
data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
Build a positive, collaborative team environment with Lifecycle safety
team members, lead by example, provide training and mentoring for less
experienced team members and operations staff, assist Operations with
appropriate allocation of resource.
Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
Provide and impart technical and process information to Lifecycle Safety
Management (LSM) and members of operational team on project specific issues.
Provide oversight and maintain a thorough understanding of project
protocol, therapeutic indication, budget and scope of work (SOW) for
assigned projects; set up and maintain project files, standards,
templates, electronic forums,
databases and workflow.
Establish and maintain effective team project service operations
communications i.e. provide regular feedback to operations team manager
and Customer Delivery manager (CDM) on project metrics, out of scope
work challenges/issues and successes; feedback effective project
performance to junior members of team.
Liaise with LSM contact
in proactively identifying issues and proposing solutions, providing
them with technical support, reports, metrics, statuses, identifying SOW
changes and potential change orders ,delegating client requests and
installation of new initiatives.
Ensure compliance to
Quintiles high quality standards and works with LSM constructively in a
matrix framework to achieve project and customer deliverables.
Participate in training across Lifecycle safety process service
offerings, participate in working groups as applicable in implementation
of new initiatives, identification and implementation of process
efficiencies.
Liaise confidently with different functional team members, e.g. project
management,
clinical,
data management, health care professionals e.g. investigators, medical monitors, site
coordinators and designees to address operational project issues.
Contribute to achieving productivity utilization and realization metrics.
Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required.
Ensure all required training is executed in a timely fashion and
documented. Work towards ensuring your individual training plan and
training transcript are reconcilable.
Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of Lifecycle safety processes and willingness and
aptitude to learn new skills across Lifecycle safety service lines.
In depth knowledge and understanding of applicable global, regional, local
clinical research regulatory requirements; i.e. Good
Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
Proven ability to meet strict deadlines; manage competing priorities.
Demonstrate effective project
management and leadership skills.
Sound judgment; independent thinking and decision making skills.
Demonstrate a flexible and receptive approach to changing demands.
Proven ability to work independently and autonomously with policies and practices.
Effective mentoring and coaching skills.
Excellent attention to detail and accuracy maintaining consistently high quality standards.
Excellent organizational skills and time
management skills.
Excellent written/verbal communication and report writing skills.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to work effectively on multiple projects simultaneously
organize own workload and effectively manage competing priorities.
