Clinical Project Associate (CPA)
Location
Secunderabad | India
Job description
About The Role
Your responsibilities include, but are not limited to:
- Support TCO Lead CTL and CTLs in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of selected study documents development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
- Under the supervision of the CTL, key contributor for preparation of CSR appendices. Support CTLs by setting up and maintaining appropriate study tracking forms including: enrollment log/trial allocations forms, site and vendor contact lists, drug shipping logs, set up and maintenance of team membership and contact lists.
- Support CTLs in managing interactions with relevant functions including Global Clinical Supply and Novartis country organizations. Support CTLs in all drug tracking (central hubs, local CPOs and sites) to ensure adequate supply, monitor expiry dates and assist in relabeling as appropriate. Support CTL in tracking all batch numbers used throughout trials.
- Provide support to CTL in the creation and maintenance of HQ TOC and ensure timely completion and maintenance of TMF in the relevant DMS.
- Support CTL in delegated aspects of trial data analysis and reporting, including attendance at all relevant study meetings (i.e. CTT and dose escalation meetings).
- Provide support in meeting scheduling and distribution of meeting agendas/minutes. Assist CTL with preparation, distribution and archiving of study tools needed at study start up and throughout trial as appropriate.
- Support the Lead CTL and CTLs for both PK and biomarker sample tracking in collaboration with the CTT and act as a liaison with sites for kits and sample shipment, sample reconciliation and associated logistics.
- Support the Lead CTL and CTLs in vendor management activities, including coordinating shipment and returns of ECG machines.
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements - Bachelor degree or equivalent education/degree qualification in life science/healthcare required.
- At least 1 year of involvement with clinical study planning, execution, reporting or publishing activities (either at a local medical organisation, investigational site, pharmaceutical company/CRO, or clinical fellowship program) preferred.
- Fluent English (oral and written)
- Good communication, organization and tracking skills.
- Detail oriented
- Basic knowledge of Good Clinical Practice; basic knowledge of scientific principles.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Division Biomedical Research
Business Unit TCO NIBR
Work Location Hyderabad, AP
Company/Legal Entity Nov Hltcr Shared Services Ind
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Shift Work No
Early Talent No
Job tags
Salary
