TMF SWAT Specialist (6 month contract)

TMF SWAT Specialist (6 month contract)

06 dic
|
Quintiles Transnational
|
Buenos Aires

06 dic

Quintiles Transnational

Buenos Aires

Description 
PURPOSE

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.


*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.  

RESPONSIBILITIES

Support the management and oversight of TMF activities for paper, electronic and customer TMF systems to ensure delivery of a high quality TMF.   
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

All responsibilities are essential job functions unless noted as nonessential (N).

Qualifications REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

(Desiderable) Previous experience of conducting file reviews of Trial Master Files.
(Desiderable) 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 desirable.
Knowledge of technology applications and reporting mechanisms relevant to records management/TMF environments, including electronic signatures and records desirable.
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
-Up to 1 year’s administration experience.
-Advanced in English.
-(Desiderable) Bachelor´s degree or advance associate degree from healthcare or science industry.

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