NewYorkRecruiter
the smart solution for New York jobs

Clinical Associate- TMF/Trial master file/QC review

Company: MaxisIT Inc
Location: New York
Posted on: June 12, 2018

Job Description:

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 ADDITIONAL - 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 Sr.Recruiter MaxisIT Inc Phone: (732) 666-0112 Fax: (732) 909-2393

Keywords: MaxisIT Inc, New York, Clinical Associate- TMF/Trial master file/QC review, Healthcare, New York, New York

Click here to apply!

Didn't find what you're looking for? Search again!


I'm looking for
in category
within


Other Healthcare Jobs


Registered Nurse (RN) - 13 wk Pennsylvania contract
Description: Cross Country TravCorps has your next Travel Nurse contract waiting for you in Pennsylvania.Great positions are available for experienced
Company: cross country travcorps
Location: Merion Station
Posted on: 06/18/2018

Medical and Dental Enrollers/Work From Home
Description: Amazing health benefits company seeking professional individuals who are motivated and are
Company: AmeriPlan
Location: Newark
Posted on: 06/19/2018

Locum Tenens Adult Inpatient Psychiatrist (Ridgewood,NY)
Description: Locum Tenens Adult Inpatient Psychiatrist Ridgewood,NY A facility in upstate New York is seeking a locum
Company: LocumTenens.com
Location: Ridgewood
Posted on: 06/18/2018


Locum Tenens Adult Inpatient Psychiatrist (Jackson Heights,NY)
Description: Locum Tenens Adult Inpatient Psychiatrist Jackson Heights,NY A facility in upstate New York is seeking
Company: LocumTenens.com
Location: Jackson Heights
Posted on: 06/18/2018

Nurse Practitioner Family Practice - JOB- (Flushing,NY)
Description: Nurse Practitioner Family Practice - JOB- Flushing,NY A well-established hospital system in beautiful upstate New York is seeking a Nurse Practitioner for their rural health Clinic. This growing group (more...)
Company: CompHealth
Location: Flushing
Posted on: 06/18/2018

Health benefit recruiter
Description: 1 Leading Health Care Provider Company is searching for Health Representatives that are looking to work FROM HOME Our company has been in business for 22 years with well over 2 million satisfied
Company: M lagace enterprise
Location: Staten Island
Posted on: 06/18/2018

Registered Nurse (RN) - No Experience Necessary! - Located in Yuma, AZ
Description: Yuma Regional Medical Center offers fulfilling careers in a state-of-the-art medical facility surrounded by a
Company: Yuma Regional Medical Center
Location: Jersey City
Posted on: 06/19/2018

Adult Psychiatrist (Newark,NJ)
Description: Adult Psychiatrist Newark,NJ Partial hospitalization program in New Jersey
Company: LocumTenens.com
Location: Newark
Posted on: 06/18/2018

Neonatal-Perinatal Physician Assistant (Astoria,NY)
Description: Neonatal-Perinatal Physician Assistant Astoria,NY Locum tenens opportunity
Company: LocumTenens.com
Location: Astoria
Posted on: 06/18/2018

Medical Recorders Coders
Description: Medical Recorders Coders We are seeking experiencedself-motivatedInpatientand Outpatient Medical Records Codersto joinone of our dynamic groups of coding professionals. This coding team provides high (more...)
Company: Mommy Jobs Online
Location: Jersey City
Posted on: 06/18/2018

Log In or Create An Account

Username:
Password:
 

Forgot password?


Find us on Facebook

Find us on LinkedIn

Get the latest New York jobs by following @recnetNY on Twitter!

New York RSS job feeds