IQVIA Clin Process
Spec bachelor’s degree in life sciences/ pharmacy/allied fields
Job
Description
Q2 Solutions is a leading clinical trial laboratory
services organization with end-to-end laboratory services and secure,
enterprise-wide biospecimen and consent management solutions. With a relentless
focus on quality and innovation, Q2 Solutions uses its global experience and
scientific expertise to transform science and data into actionable medical
insights that help customers improve human health. A joint venture of
IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the
best of each parent organization’s clinical trials laboratory services
capabilities to fulfill its mission of treating each sample as if a life
depends on it.
RESPONSIBILITIES
1) On time completion of assigned role specific trainings (self-learning
courses, instructor led training, acknowledgement of e-SOP/WI etc.) and related
assessment
2) Under no to minimal supervision perform centralized monitoring activities
for the assigned projects which includes but is not limited to:
a. Loading and maintaining the working databases with details of participating
sites
b. Coordinating for needful accesses for the site, clinical and project
management teams
c. Ensuring on-time completion of documentation(s) that form a part of the
regulatory dossier for kit and sample shipment
d. Ensuring on-time release of correct, complete and accurate patient
laboratory report by following up on the associated pending activity(ies) and
related team(s)
e. Ensuring that documentation is available for all activities performed for
real-time audit readiness
f. Participation in departments initiatives/drives as
applicable
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
1) Basic knowledge of applicable research and regulatory requirements, i.e., ICH GCP and relevant local laws, regulations and guidelines
2) Excellent skills in MS Applications (Microsoft Word, Excel and PowerPoint)
3) Excellent analytical skills
4) Excellent verbal and written communication skills
5) Excellent data entry skills
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
1) Minimum bachelor’s degree in life sciences/ pharmacy/allied fields
PHYSICAL REQUIREMENTS
1) Extensive use of keyboard requiring repetitive motion of fingers.
2) Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
3) Regular sitting for extended periods of time.
4) May require working in shifts.
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