CA-795 | Associate TMF Specialist

CA-795 | Associate TMF Specialist

21 Dec
Pharm-Olam International

21 Dec

Pharm-Olam International


Job Description


The TMF Specialist I is responsible for scanning, uploading, Indexing and reviewing documents filed in the eTMF, as well as verifying eTMF Inspection Readiness to ensure clinical trials are conducted in accordance with ICH-GCP and applicable regulations.

Your Role As a member of Global TMF Management, the TMF Specialist is expected to hold and contribute to process improvement with a focus on value to our business and meeting client needs

To liaise with study teams and other Global TMF Management staff in order to fulfil job responsibilities and activities with supervision

To obtain knowledge and skills to process study TMF documents in accordance with study requirements as per study-specific processes, Pharm-Olam SOPs/WIGs, GCP and regulations

Timely complete the activities related to document processing which includes: document receipt and review, scanning and indexing, quality control, filing, forwarding or return to client/study teams and archiving

To complete assignments in accordance with specified timelines, Pharm-Olam SOPs/WIGs, GCP and applicable regulations

To maintain study TMF files as per study and/or client requirements or in accordance with Pharm-Olam SOPs/WIGs and applicable regulations

To inform the TMF Manager of training issues, project activities, quality issues and timelines as directed

To participate in client and/or Pharm-Olam audits as necessary

To participate in document archiving activities as necessary

To participate in training related to fulfilment of responsibilities as required by Pharm-Olam and/or the client

Maintain regular and effective verbal and written communication with Pharm-Olam project team members

Attend training (including department-specific) sessions, as applicable.

Other duties as assigned.

Working relationships:

Report to Manager/designee in Global TMF Management department

Collaborate with Study TMF Lead, POI study teams and all Pharm-Olam staff.

Qualifications Bachelor's degree (Life Sciences, Medicine, Pharmacy, Nursing, business administration, or related discipline) preferred, and/or combination of education and experience.

Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred

Minimum of 1 year of clinical trial experience with clinical document management / administration experience a strong plus

Thorough knowledge and strong working experience on eTMF/TMF files management

Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements preferred

Computer literate with intermediate to advanced skills in Microsoft Office suite

Good understanding of Pharm-Olam SOPs preferred

Good written and verbal communication skills

Excellent interpersonal and organizational skills

Ability to work independently and to effectively prioritize tasks

Ability to manage multiple projects

Attention to detail.

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