Rani Pavitra Pervela

Mobile: +1-732-***-****

E-Mail: adwcbr@r.postjobfree.com

CAREER OBJECTIVE:

To obtain dynamic, challenging position in a high quality, ethical oriented and leading Clinical research area where my resourceful experience and academic skills will add value to organizational operations.

Professional Summary:

Expertise in managing clinical projects within time, budget, and quality expectations. NDA and ANDA experience, within an orphan/rare disease therapeutic area. Thorough knowledge of GCP, ICH guidelines and awareness of global regulatory requirements/differences for clinical development. Detailed and process oriented, with excellent project management skills, including risk assessment and contingency planning. Leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills. Excellence in cross-functional matrix and/or cross-cultural partnership. Effective communication skills with all sponsor companies, IRBs. Ability to work well with all departments and to represent the institution and physician investigators in clinical research at professional meetings, effectively.

Jan 2022 to till date.

Working as a Quality Assurance Training coordinator & clinical study coordinator, KVK Tech, Inc. U.S.A

Review of clinical protocols/documentation for outsourced Clinical Studies.

Coordinate with CROs for study related communications. Review the records and filing standards in the CRO sites to ensure that all study-related documents filed and maintained as per Good Documentation Practice and Good Clinical Practices.

Review of regulatory queries and responses related to outsourced clinical studies.

Verify the third-party monitoring reports, protocol deviations, documentation of Adverse events and serious adverse events (SAEs) as per regulatory norms and internal SOPs.

Prepare plans for individual employees throughout the life cycle starting from inductions to exit. This shall include all internal or external trainings.

Match by facilitating the best learning tool through a variety of delivery methods.

Monitor the training evaluations with appropriate tracking tool and report in summary the training outcomes with appropriate recommendations and plan of action.

October 2018 to Jan 2022

Worked as a Technical Service Associate, KVK Tech, Inc. U.S.A

Review of clinical protocols/documentation for outsourced Clinical Studies.

Coordinate with CROs for study related communications. Review the records and filing standards in the CRO sites to ensure that all study-related documents filed and maintained as per Good Documentation Practice and Good Clinical Practices.

Review of regulatory queries and responses related to outsourced clinical studies.

Verify the third-party monitoring reports, protocol deviations, documentation of Adverse events and serious adverse events (SAEs) as per regulatory norms and internal SOPs.

Ensure the CRO SOPs, Policies, and Work Process documents are as per International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and GCP guidelines governing the maintenance of clinical trial documentation.

Provide investigation expertise and technical writing expertise to perform and document process Deviations and Events.

Implements Change Control management in production and engineering.

Jun 2010 to June 2017

Worked as Executive in Global clinical operations, Mylan Laboratories Ltd.,

Monitoring the progress of clinical studies at investigative sites, and ensuring that clinical studies were conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Review of SOPs, study protocol, CRFs, ICFs and reports.

Prepared FDA submissions, Technical Files, Canadian Applications and International Dossiers for new products and product changes.

Prepared protocols/documentation for Clinical Studies and coordinated and maintain study communications.

Coordinating with CROs and internal customers to ensure the studies are executed in accordance with the project plan and regulatory requirement to meet timelines.

Tracking and Updating of all outsourced Pilot and Pivotal Bioequivalence studies as a part of Project Management.

Preparing and monitoring of study budgets.

Execution of study specific contracts with CRO.

Managing SAP Entries and updating to finance department.

IT FORTE:

MS Office, MS Project, MS Excel exp (V-Look up), Data reconciliation, SAP, SAS –Reports, SDTM exp (basic) efficient in browsing, handling of track-wise software.

ACADEMIA: Bachelor of Pharmacy