Team Member €“ CRF Designer Neptune Consultants - Mumbai,.."R"

Team Member €“ CRF Designer
Neptune Consultants - Mumbai, Maharashtra

Role and Responsibilities:
CRF Designing and Typesetting:
Understand
the study protocol and the timelines.

Design
paper data acquisition components, referred to as Case Report Forms (CRFs) ie; to produce draft versions of English CRF
documents using client’s customized Adobe FrameMaker Software Version 8.0, in-line
with the requirements laid out by client and study protocol.

  Determine appropriate CRF designs to capture
the data required by the study protocol and which adhere to client Paper
CRF - Standards, Principles, Development process and Good Clinical Practice.

Create English diary cards, PROs and worksheets from scratch using
the study protocol.


translations to create country specific versions of CRFs, diary cards and
worksheets. This could involve sourcing translated versions of CRF documents
from client Local Operating Companies and/or client
suppliers. 
Create Translation Tracking Sheet for respective study.

Peer reviewing of final versions of all CRFs to ensure quality,
accuracy and technical requirements for CRF printing.

client

Perform edits and updates to existing CRF
documents as requested by the client study team until an approved and final CRF
version is reached, including standard library components.

Arrange for the printing of CRF materials at
the existing CRF printing facilities. For certain requests, specify the
printing requirements which is appropriate for the study.


might need to be extended or reduced, based on study specific requirements
and/or staffing levels for drafting,
finalizing and printing CRF documents.

  Manage CRF print and dispatch requests in client's repository.

  To
be aware of updated client quality
standards and undertake any relevant training for the same if required.

 Adhere to SOPs/Regulatory
requirements/project specific guidelines.

 Identify,
communicate and resolve data issues effectively.

  Provide
inputs/status reports on monthly basis during the tenure of life cycle of the
project.

  Suggest
new best practices, more efficient ways of working and methods for improving
the quality of the client CRF
product.

Assist
in the collection of metrics relating to CRF deliverable.

Requirement:
Academic

Qualification:
 Bachelors/Masters Degree in Life
Sciences/Pharmacy.

At least 1 year of experience in the field of
clinical research/clinical data management.

˜
Understanding the clinical study protocol and
determining appropriate CRF designs for capturing high quality data to support
the protocol.

General objectives and principles of clinical
trials and clinical data capture. ˜
Awareness of ICH/GCP guidelines and 21 CFR part

• 11.

Computer
Literate (good knowledge of MS Office, FrameMaker Tool).

Excellent interpersonal and
communication skills (Verbal
and Written).

 Knowledge of Medical/Bio sciences.

Time management skills.

Collaboration and team work.

Assertiveness in explaining issues and ability
to make recommendations.


Effective decision making at a study team level
with consultation with team members and Team Lead.

Others:
  Capability to lead by motivation
and example.
˜ Ability to prioritize schedule
and organize.

  General knowledge of Clinical
Trials and Pharmaceutical Industry

  Ability to be flexible. CLICK HERE TO APPLY