SHRINA PUNJABI

CAREER HISTORY

From Dec **** to Present: Associate Director, Operational Study Lead

Allergan – Irvine, CA

Therapeutic Area/ Indication/ Lab Experience

·GI, Phase II and III, multi-country, pediatric

Key areas of Responsibility:

Lead clinical operations activities with functional groups.

Provide guidance with planning, conducting and reporting of clinical data.

Conduct study oversight for development, maintenance of timelines, risk mitigation, change of scope

Oversee CRO

Ensure study is audit ready

Lead internal and external calls for stakeholder

From Nov 2015 to Sep 2018: Sr. Global Project Manager

PPD – home-based

Therapeutic Area/ Indication/ Lab Experience

·AML, Phase I, USA (3 year)

·Non-Small Cell Lung, Phase II/Phase III, multi-country (7 months)

·Colorectal, Phase II, multi-country (2 years)

·Lymphoma, Phase II, multi-country (6 months)

·Breast Cancer, Phase I/II, multi-country (1 year)

Key areas of Responsibility:

·Manage program level issues and process for clients

·Conduct Bid Defense Meeting

·Overall coordination and management of clinical trials from startup to closeout

·Direction of the technical, protocol-specific and operational aspect of assigned trials

·Collaboration with major functions areas and vendors to identify and evaluate fundamental issues on projects, interpret data, make good business decisions and ensure timely implementation of solutions

·Ensuring all project deliverables meet customers’ expectation as well as PPD standards

·Communicating timelines and project expectation to team and stakeholders in a timely manner

·Accurate forecast for finances, team needs, as well as business demands

·Create project budgets and consult with other departments to prepare benefit models

·Review and prepare protocols, CSR, study documents, and other relevant documents

From Apr 2014 to Aug 2015: Clinical Team Lead

Chiltern Oncology USA – home based

Therapeutic Area/ Indication/ Lab Experience

·Myeloma, Phase I, USA (5 Months)

·Non-Small Cell Lung, Phase II, multi-country (1 Month)

·Hepatocellular, Phase II, USA (2 Months)

·CML (4 months)

Key areas of Responsibility:

·Overall operational planning and activities for the implementation and conduct of studies, including oversight of data management activities in compliance with GCPs, SOPs and standards within established timelines and budgets.

·Ensuring high quality data is delivered to client

·Interacting effectively with support functions (Data Managers, Vendors, CRAs, etc), with internal and external team members

·Work with management when new project contracts are being negotiated in order to provide feedback about feasibility and optimum project conduct including recommending sites and countries

·Arrange, or help with the arrangement of, project kick-off meetings (if budgeted for in the contract with the sponsor)

·Establish ongoing priorities with the sponsor

·Prepare ethics submissions and regulatory submissions (If required)

·Prepare or assist with the preparation of investigator contracts

·Write or review protocols

·Review case report forms

·Write or review Clinical Study Reports (CSR)

·Train and share experience with less experienced team members

·Interview potential members of the team

From Nov 2010 to Feb 2014: Sr. Clinical Research Associate III/ Associate Project Manager

Quintiles - Home-based

Therapeutic Area/ Indication /Lab Experience

·Oncology: ( all solid tumor)

·Breast Cancer - (Phase I) – 1 year

·Melanoma (2) - (Phase II/III) – 1 year

·T-Cell and B-Cell Lymphoma (2) - (Phase I/II/III) – 3 years

·Head and Neck ((Phase I/II) – 3 years

·GI (Phase I/II) – 3 years

·Non-Small Cell Lung (Phase I/II) – 3 years

·Infectious Disease:

·Influenza Disease - (Phase I/II/III) – 6 months

·Cardiovascular:

·Coronary Artery Disease - (Phase II/III) – 1 year

·MI (Phase I/II) – 1 year

Key areas of Responsibility:

·Reviewed regulatory documents

·Responsible for resolving site issues and problems, in house and on-site.

·Assisted in writing Monitoring Plan, Communication Plans, Informed Consent, Protocol Review and Writing, Timelines, etc.

·Created, tracked and reported on project timelines.

·Produced and distributed status, tracking and financial reports for internal and external team members and senior management.

·Assisted the clinical project manager(s) with budget allocation and approval of invoices.

·Served as primary back up project contact with Sponsor and internal project team to ensure communication is maintained and reporting schedules are adhered to.

·Identified out of scope project work. Escalate findings and action plans to appropriate parties.

·Coordinated data gathering for the development of proposals for new work.

·Prepared and present project information at internal and external meetings.

·Coordinated with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes.

·Undertook clinical project management activities as directed by Clinical Project Manager.

·Trained and coordinated the work of more junior project support staff.

·Provided direct site support (on site visits)

·Planning for and managing of strategic and/or complex global clinical trials

From Feb 2010 to Oct 2010: Sr. Clinical Site Research Manager

KCI c/o Medpace – San Antonio, TX

Therapeutic Area/ Indication /Lab Experience

·Healthy Human:

·Air Leak (4) (Phase I) – 8 months

·Tissue Repository (2) - (Phase I) – 8 months

·Surgery:

·Hip and Knee total Arthroplasty - (Phase I) – 8 months

·Oncology: ( all solid tumor)

·Diabetic Foot Ulcer (Phase I) – 8 months

Key areas of Responsibility:

·Monitored activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols.

·Reviewed regulatory documents as required and prepare site visit reports.

·Responsible for resolving site issues and problems, in house and on-site.

·Multiple studies and works both independently and in a team environment

·Assisted in writing Monitoring Plan, Communication Plans, Informed Consent, Protocol Review and Writing, Timelines, etc.

·Trained CR Assistants

·Lead CRA

·Reviewed Trip Reports

From Sep 2007 to Jan 2010: Clinical Site Research Manager II

ICON Clinical – Lake Forest, IL

Therapeutic Area/ Indication /Lab Experience

·Oncology: (all solid tumor)

·Germ Cell Tumor (Phase I) – 1 year

·Colorectal Cancer (Phase I/II) – 1 year

·Breast Cancer - (Phase I) – 3 years

·Infectious Disease:

·Influenza Disease (3) - (Phase I/II/III) – 3 years

·Gastrointestinal:

·Gastroesphogeal Reflux Disorder (Phase I) – 3 years

·Cardiovascular:

·Coronary Artery Disease- (Phase II/III) – 3 years

·Endocrinology:

·Friedrich’s Ataxia (2) (Phase I/II) – 3 years

·Women’s Health:

·Contraception (Phase I/II) – 3 years

Key areas of Responsibility:

·Reviewed regulatory documents as required and prepare site visit reports.

·Responsible for resolving site issues and problems, in house and on-site.

·Multiple studies and works both independently and in a team environment

·Assisted in writing Monitoring Plan, Communication Plans, Informed Consent, Protocol Review and Writing, Timelines, etc.

·Trained CR Assistants

QUALIFICATIONS & TRAINING

2003 - 2007 B.S in Biochemistry University of Illinois at Chicago

2011 ICH/GCP certification Barnett

2013 ICH/GCP certification Barnett

ADDITIONAL SKILLS

·Microsoft Office: Word, Excel, PowerPoint, Access

·Operating Systems: Microsoft Windows NT4 2000, XP, Vista, 7; Windows Server 2000, 2003, 2008; Apple/Mac: OS 9,

·Databases: Microsoft Access 10, Symetric X, Oracle X, Siebal, Inform 4.0, Inform 4.5, Inform 4.6, Inform 5.0, Medidata Rav4, DataLabs

·Statistics: SAS® 8.02, 9.1,9.2, 9.3

·CTMS: etrials eCRF, Merge EDC, Siebal, Oracle

·Other Software: Adobe Acrobat 10; PhotoShop 5

·Other Special Skills/Tools: X-Ray Technician; Bacterial Culture Identification, Chemical Kinetics Measurements

·Fluent in Gujurati (Indian Dialect), Hindi (Indian Dialect), Conversational Spanish, Conversational French

LOCATION: LAGUNA NIGUEL, CA

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