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Careers
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Position: Clinical Project Manager
Job Description
This is an fantastic opportunity for Senior CRA’s/Lead CRA’s/Asst
Project managers who want to move to the next level. This involves day
to day management of a team of Clinical Research Associates. Right
candidate must ideally have 2-3 years Lead/Senior/Asst Project Manager
CRA experience. The CPM is responsible for the coordination and
management of all Clinical Operations Project Team members for their
designated global projects. To achieve these goals, the CPM will
implement and manage the necessary training, tracking and quality
systems within the department.
Role and Responsibilities
1.Taking a proactive approach and leading the team from the front to
achieve goals within timeline and budget with uncompromised quality.
2. Manage all Clinical Operational aspects of allocated studies in
compliance with ICH GCP.
3. Serves as the primary clinical operations contact for the study team,
Client and vendors for assigned study.
4. Develops Clinical Tools eg. Monitoring Plan, Monitoring Guidelines in
conjunction with the Data Quality Plan.
5. Responsible for the implementation and training of standardised
clinical monitoring processes within the Study and according to
corporate standard policies.
6. Coordinates all start up activities and ensures that essential
document quality meets the expectation of Regulatory Compliance Review.
Ensures timely EC and Regulatory submissions.
7. Reviews monitoring visit reports
8.Manages CRF collection and query resolution.
9. Performs co-monitoring visits
10. Represents clinical operations at hand-over meetings.
11. Responsible for clinical resource management, assignment, delegation
of clinical responsibilities and additional resource requirements.
Desired Candidate Profile
Bachelor or higher graduate degree in a science related field
Experience of leading a team of Clinical Research Associates (CRA's)
after 3-4 years of extensive monitoring experience as a CRA yourself.
Ability to lead and motivate remote teams.
Excellent organisation skills.
Excellent judgement and decision making skills.
Effective oral and written communication skills.
Excellent interpersonal skills and problem solving abilities.
Proficient knowledge of several medical/therapeutic areas and medical
terminology.
Expert knowledge of all ICH and FDA guidelines
Ability to travel
Company Profile
Roxaane is a full contract research organization providing the
entire gamut of Clinical Research services. Our clients and partners
include pharmaceutical, biotechnology, medical device and academic
organizations . Roxaane applies innovative technologies, therapeutic
expertise and a commitment to quality to help its clients and partners.
We currently have offices in Chennai, Hyderabad and Kolkata.
Email Address:
hr@roxaane.com
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