Operations Specialist
Quintiles Transnational - United States

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PURPOSE
Review, assess and process Lifecycle Safety data and information, across all service lines received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOP’s and internal guidelines. May provide oversight on projects with limited complexities for activities on small to medium service operational projects.

JOB RESPONSIBILITIES

· Receive, triage, review and process Lifecycle Safety 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 of secondary review.

· 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 to individual 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 Lifecycle Safety data.

· Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.

· Mentoring less experienced or newer staff members. May provide oversight on operational activities and have a sound 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.

· May provide oversight role to impart technical and process information to the LSM point of contact and members of operational team.

· May provide an oversight role to perform operational and collaborative LSM tasks as directed by Lifecycle Safety Infrastructure.

· Participate in team meetings and provide regular feedback to operations team manager and lifecycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes.

· Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.

· Work with LSM constructively in a matrix framework to achieve project and customer deliverables.

· Participate in training across Lifecycle Safety service offerings. Provide project-specific operational process training to junior team members, monitors and investigative site personnel, as appropriate.

· Liaise 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 achievement of departmental goals e.g. utilization realization and productivity 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
· Excellent knowledge of Lifecycle Safety processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.
· Good understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs)
· Proven ability to meet strict deadlines; manage competing priorities and changing demands.
· Proven ability to follow instructions/guidelines, work independently and on own initiative.
· Good understanding of operational metrics, productivity and REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
· Excellent knowledge of Lifecycle Safety processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.
· Good understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs)
· Proven ability to meet strict deadlines; manage competing priorities and changing demands.
· Proven ability to follow instructions/guidelines, work independently and on own initiative.
· Good understanding of operational metrics, productivity and initiatives.
· Excellent attention to detail and accuracy and maintain consistently high quality standards.
· Effective mentoring skills.
· Excellent written and verbal communication and report writing skills.
· Ability to be flexible and receptive to changing process demands.
· Sound judgment; decision making skills.
· Ability to work effectively on multiple projects simultaneously. Organize own workload and effectively time 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 a Scientific or Healthcare discipline and 1 year’s experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc) or equivalent combination of education, training.

PHYSICAL REQUIREMENTS
· 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.
· May require occasional travel.
initiatives.
· Excellent attention to detail and accuracy and maintain consistently high quality standards.
· Effective mentoring skills.
· Excellent written and verbal communication and report writing skills.
· Ability to be flexible and receptive to changing process demands.
· Sound judgment; decision making skills.
· Ability to work effectively on multiple projects simultaneously. Organize own workload and effectively time 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 a Scientific or Healthcare discipline and 1 year’s experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc) or equivalent combination of education, training.

PHYSICAL REQUIREMENTS
· 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.
· May require occasional travel.

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Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...