At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
TMF (Trial Master File) Health is a new multidisciplinary team of TMF Advisors & Specialists, who will support global teams to deliver a high quality Trial Master File for our customers. You will have opportunity to work globally and to collaborate with many different teams involved in the management of clinical trials, also presenting you with insights for future career progression.
To actively provide qualified GCP Records Management support within a global network of programs/systems for customer Trial Master File (TMF) Records. Serve as the liaison between Records Management and Functional Operational /Study Teams to support adherence to GCP records management and customer specific requirements, driving required activities to develop a collaborative delivery of a quality TMF for our customers, including key performance indicators.
Act as an SME supporting the management and oversight of TMF activities for paper, electronic and customer TMF systems to ensure delivery of a high quality TMF.
SME on all designated Sponsor-specific TMF requirements (e.g. file format, process)
Accountable for delivery of assigned TMF activities in accordance with project requirements & SLA’s.
Conduct review of documents with compliance to Quintiles or customer file plans and SOPs.
Serve as a TMF contact for documentation to the project team, and cross functional departments to ensure high quality TMF deliverables are met on time.
Follow processes for set up, maintenance, and support for assigned TMF projects as required.
Monitor, identify and record quality problems, suggest, initiate, recommend or provide solutions as appropriate.
Manage documentation associated with assigned clinical trials.
Facilitate collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor.
Follow applicable SOP’s to ensure completeness & accuracy of the TMF.
Follow records management tasks, policies, and procedures.
Provide support & involvement with internal quality or audit process’s as relevant.
Collaborates on TMF Quality for assigned sponsor trials
Reports TMF health findings at required frequency
Alert Project team and TMF Quality PM to any potential TMF Health issues
Provide regular updates on performance to SLAs
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Previous experience of conducting file reviews of Trial Master Files essential.
In Depth Knowledge of and skill in applying applicable clinical research regulatory requirements/global international records standards to the area of expertise; e.g. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines; DIA Reference Model.
Knowledge of technology applications and reporting mechanisms relevant to records management/TMF environments, including electronic signatures and records.
Strong software and computer skills, including MS Office applications.
Ability to establish and maintain cooperative relationships, and work effectively with all levels of personnel on TMF management issues across multidisciplinary teams globally.
Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
Excellent oral/written communication, and interpersonal skills.
Good problem solving skills.
Effective time management and organizational skills.
An ability to demonstrate a critical eye & strong attention to detail.
Ability to adapt quickly to a rapidly changing environment.
Self-motivation and ability to work independently under limited direction or in a group setting as required.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
1-3 years applicable experience in TMF/records management environment.
Extensive use of keyboard requiring repetitive motion of fingers.
Regular sitting for extended periods of time.
Use of telephone/virtual meeting technology and face-to-face communication requiring accurate perception of speech.
Working across geographies and different time-zones with an ability to appreciate cultural working differences.
May require occasional travel.
Did You Know?
* Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNE’s World’s Most Admired Companies® 2016 list
* Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute
Primary Location: Slovakia