Hi,

Hope you are doing well.



I would like to check your interest & availability for below mention
position. If you are interested kindly reply me back with your updated
resume, contact details & best time to reach you.



Clinical PM

Preferred location is Memphis, but will consider candidates in Andover, MA
or Fort Worth, TX.

Duration:  6+ months

Phone then Skype

Must have clinical trial software implementation experience!



*NOTE from IT Director who is leading the Clinical Informatics project that
Sr. PM contractor will be supporting:*

I would like to see experience details from candidates for each of the 6
requirements in ‘Required Profile’ below to be submitted with resumes:

•             #1 below – Include experience and familiarity with GAMP, Part
11, and the types of validation documentation that are customary in life
sciences.

•             #2 – Although hospital experience is credible, it is  different
enough in nature from Clinical experience at a medical device, pharma, or
biologics company that it represents a functional gap for this project.  Really
need IT/Sr. PM experience with ‘clinical trial software implementations’.

•             #5 – Include specific experience details to the point about
Critical Path.

•             All in all, search for someone with a life sciences and
ideally, clinical research systems, IT project management background.



*Required Profile – Sr. PM, Clinical Informatics Project (requires specific
expertise as ‘must haves’):*

1)            Validation systems experience (must have).

2)            Clinical experience – managed IT projects in support of
clinical affairs / clinical trials at a medical device, pharma, or
biologics company; familiar with DIA (Drug Information Association)
reference model, eTMF (electronic Trial Master File) standardization
efforts (must have).

3)            Document Management System experience – vendor is Veeva Vault
eTMF.

4)            Senior PM experience – strong project management; technical
project management, ability to follow and adhere to IT SDM (Software
Development Methodology) and PMO (Project Management Office) governance.

5)            MS Project experience – how to manage Critical Path (must
have).

6)            Able to deal with ambiguity and resourceful enough to figure
out tasks and assignments.



*Waiting for your response…*

Best Regards

*Ravi Nigam*

978-558-4666 Ext. 101

[email protected]

*TekNavigators,* *LLC*

8875 Hidden River Parkway

Suite 300

Tampa, FL 33637



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