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Clinical Associate- TMF/Trial master file/QC review

Job Title:Associate, TMF Process Management and QC- Direct Hire Position
Location-Woodcliff Lake, NJ

Job Description:
The Associate, TMF Process Management and QC, will be responsible for performing daily support activities ensuring that the Trial Master File (TMF) is compliant and Inspection Ready. The eTMF system has over 1,000 global users, including CROs. Functions include TMF set-up, managing TMF file structures and archiving of Trial Master Files; eTMF query resolution, eTMF user support and training, and assisting with the oversight of the eTMF vendor; performing quality control review of study documents to ensure they adhere to SOPs and meet regulatory requirements and ICH guidelines. This role will be required to work collaboratively across functional areas and contribute to positive team relationships, both locally and globally. The Associate, TMF Process Management and QC, will lead initiatives and will serve as a subject matter expert in TMF Process Management.
Job Qualifications
Bachelor's degree, preferably in a scientific discipline or equivalent work experience
Min of 3 years in pharma
Must have good understanding of clinical development, including regulatory documents and regulatory requirements (including ICH and GCP guidelines), and be able to interpret and make decisions based on the interpretation
Must have strong document management skills, including experience with review of Regulatory Documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines
Knowledge/understanding of TMF requirements and technologies to suport document collection and archiving; eTMF experience preferred
Must have critical reasoning skills, including the identification and resolution of complex problems
Must be proficient in MS Office
Must have strong verbal, written and interpersonal communication skills
Shows high level of initiative and has ability to work independently
- QC review experience of the TMF (Trial Master File) is key. Usually candidates with a Clinical Operations or CRO background will have this experience and understanding that we need to function in our group, and it is essential.
- Understanding of the TMF and what it represents
- Experience with processes related to the collection and archiving of the TMF documents
- We prefer someone with experience related to eTMF systems but it is not required. The experience should be understanding how a system works and how best to use the system to be able to provide guidance to others. This does not include scanning and indexing of documents. Our eTMF vendor Phlexglobal performs this for us.

If you are qualified, available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please call me ASAP at (732) 666-0112, even if we have spoken recently about a different position. If you do respond via e-mail please include a daytime phone number so I can reach you. In considering candidates, time is of the essence, so please respond ASAP.

Thanks & Regards

Sona Mehra
MaxisIT Inc
Phone: (732) 666-0112
Fax: (732) 909-2393

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