Dear *Professional*,
Hope you are doing great today...
This is *Babu, BDM from Pantar Solutions INC*, we are an Information
Technology and Business Consulting firm specializing in Project-based
Solutions and Professional Staffing Services. Please have a look at below
positions which is with our Clients and let me know if you have any strong
and suitable resume. I would really appreciate if you share *most recent
updated resume for below position*:
*Job Title: Senior Clinical Operations Regulatory Specialist - Level 2 *
*Location: Cambridge, MA*
*Duration: 6 Months Contract*
* Duties:* The Senior Clinical Operations Regulatory Specialist
Contractor will be responsible for ensuring that SDP Oncology studies have
comprehensive and quality Trial Master Files (TMFs) ready for audits and
inspections according to Veeva processes. Ensure accountable functions are
in compliance with the requirements of the TMF SOP and Veeva work
instructions. Support, consult and provide TMF guidance to staff during the
full lifecycle of the study, including planning, set-up, maintenance, QC
and closure of the study TMF.
Responsible for system administration and overall system maintenance.
Responsible for training all users of the eTMF and ensuring training
program is kept up to date with system and procedure trainings.
Responsible for overall quality, maintenance, and completeness of Trial
Master Files.
Identify trends or quality concerns and oversee resolution of any
issues.
Work closely with Information Technology to ensure system validation is
maintained.
Work closely with Clinical Operations and Regulatory Affairs to ensure
compliance with regulatory requirements.
Act as a liaison between the Site IRBs and Clinical team to resolve
queries and concerns.
Prepare and assist in submission of protocol amendments, IND safety
reports, consent form changes, and continuing reviews.
Perform investigation of deviations and monitoring of Corrective
actions & preventive actions (CAPA) relating to non-compliance issues and
findings.
Provide mentorship and training to junior members of the team.
Oversee TMF maintenance done by CROs and ensure final transfer of TMF
is sufficient to support any potential regulatory filings.
Author and/or contribute to SOP, WI, and Job Aids to ensure robust
training of TMF management.
* Other duties as assigned.*
* This is a REMOTE ROLE and Covid-19 Vaccination is required*
* Skills:*
* 2-3 years of clinical research experience in academic and/or industry
settings; oncology experience strongly preferred.*
* Prior eTMF administration required.*
Demonstrate a comprehensive knowledge of Good Clinical Practice, Good
Documentation Practice, and International Council for Harmonization E6(R2).
Knowledge of, and direct experience with Trial Master Files, experience
with electronic TMF systems is required.
Fundamental knowledge of the conduct of clinical trials is preferred.
Strong focus on teamwork, attention to detail, excellent organizational
skills. Must have ability to prioritize, and the ability to work in a
multi-task environment.
Must be able to work independently and professionally.
Must have ability to coach and oversee junior members of a team and
serve as an escalation point within the team.
This is a REMOTE ROLE and Covid-19 Vaccination is required
* Keywords:*
Education: Bachelor's degree or higher in life sciences, health
sciences, nursing, pharmacy, or related field.
*Note: For submission, we need most recent I94 clear copy (For H1B's,
EAD's) along with VISA and DL copies*
*Kindly don't share fake resumes and fake copies for above roles, it wont
works.*
*Thanks & Regards,*
Babu
Pantar Solutions Inc
11605 N Community House Rd, Suite 102,
Charlotte NC 28277
Contact: 1 (704) 368-8464
E-Mail: [email protected]
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