DOCS GLOBAL (Senior) Clinical Research Associate ( CRA II or Senior CRA) Clinical
Statistical Programmer
Description
Excellent
opportunity to work in a fast paced environment. Find below the requirement:
Solid work
experience in a programming role supporting clinical trials in the
pharmaceutical industry following standard operating procedures and working
practices.
Proven
experience in supporting, or leading programming support for multiple clinical
trials and submission activities (or equivalent).
Proven
experience in development of advanced MACROs (such as MACRO's to support
analysis data set and TFL creation) with high programming efficiency; strong
programming and problem-solving skills.
3+ years work
experience in a programming role preferably supporting clinical trials/ or in
the pharmaceutical industry following standard operating procedures and working
practices.
Advanced
knowledge of experience with SAS and other relevant programming software.
Experience in
developing Safety datasets and TFLs in line with sponsor specifications. Should
have worked on development/validation of all complex safety datasets such as
ADLB, ADAE, ADEG, etc.
Should
possess complex dataset programming.
OPTIONAL: CRT
tasks – Define.xml , Data derivation document creation, etc or Pooling submission
for safety
(Senior) Clinical Research Associate ( CRA II or Senior CRA)
Description
Due to continued growth, we are looking for a Clinical
Research Associate (Level II or Senior) to work for a global and prestigious
pharmaceutical company.
This is a full time permanent role. Office-based in Kiev.
Previous experience in on-site monitoring is required or
work experience as a sub-investigator.
Requirements
Experience in on-site monitoring of oncology clinical trials
would be an adtvantage
Previous experience as a Clinical Research Associate (CRA)
Willingness to travel with occasional overnight stay away
from home.
Fluent English.
Good written and oral communication skills.
Be able to work office-based in Kiev
Summary of the job
CRA serves as primary contact point between the sponsor and
the investigational site. A CRA is assigned to clinical trial sites ensuring
inspection readiness through compliance with the clinical research protocol,
company's Standard Operating Procedures (SOP), codes of Good Clinical Practice
(GCP), applicable regulations and guidelines from start-up through data-base
lock.
Responsibilities include site selection, pre trial
assessment, subject recruitment and retention planning, site initiation,
monitoring and close-out. Partnera with the CTA/IDA, LTM and GTM to ensure overall
site management while performing trial related activities for assigned
protocols. May contribute to process improvement, training and mentoring of
other CRAs.
PRINCIPAL RESPONSIBILITIES
Participates in site feasibility and/or pre-trial site
assessment visits, providing recommendation from local area about
site/investigator selection in collaboration with the trial team
Acts as primary local company contact for assigned sites for
specific trials.
Attends/participates in investigator meetings as needed.
Responsible for executing activities within site initiation
and start-up, site monitoring, site management and site/study close-out
according to internal SOPs/WIs/IFUs and policies.
Ensures site staff are trained and the corresponding
training records are complete and accurate at any time point during all trial
phases.
Contributes to site level recruitment strategy
Ensures site study supplies (such as Non-IP, lab kits, etc.)
are adequate for trial conduct.
Ensures that clinical drug supplies are appropriately used,
handled and stored and returns are accurately inventoried and documented.
Ensures site staff complete the data entry and resolve
queries within expected timelines.
Ensures accuracy, validity and completeness of data
collected at trial sites
Ensures that all AEs/SAEs/PQCs are reported within the
required reporting timelines and documented as appropriate.
Maintains complete, accurate and timely data and essential
documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial
Master Source and Sharepoints.
Fully documents trial related activities in particular
monitoring. Writes visit reports and uploads into eTMF
Collaborates with Local Trial Managers for documenting and
communicating site/study progress and issues to trial central team.
Prepares trial sites for close out, conduct final close out
visit.
Negotiates investigator budgets at site level, if
applicable.
Tracks costs at site level and ensure payments are made, if
applicable.
Establishes and maintains good working relationships with
internal and external stakeholders, in particular investigators, trial
coordinators and other site staff.
Clinical Statistical Programmer
TO APPLY CLICK HERE
Clinical Research Associate ( CRA II or Senior CRA)
TO APPLY CLICK HERE
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