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Project Manager Clinical Research

Location:
Jacksonville, Florida, United States
Posted:
December 10, 2018

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Resume:

Priyajeet Parekh

ADDRESS : **** **** **** * *** *38, JACKSONVILLE, FL 32216

CELL # +1-904-***-****

Project Management Clinical Operations Resource Management Line Management Strategic Management

Snapshot

A seasoned professional with nearly 14 years of experience in Project Management, Clinical Operations, Resource Management, Strategic Management, Key Account Management and Business Development.

Efficiently handled and completed more than 30 clinical studies.

Dependable employee for the company at the time of regulatory inspections. Have successfully managed more than 25 USFDA inspections and 4 other regulatory inspections. All inspections went well and data was accepted by the regulatory. USFDA inspectors were happy with the conduct of study, documentation and management.

Possess sensitivity to deliver projects within the committed time & cost parameters; demonstrated ability to direct and motivate teams to complete projects meeting specifications and deadlines.

Able to identify GAP and leverage competencies to drive growth, reduce costs, improve operational performance and quality.

Demonstrated excellence in interacting with clients, developing proposals and costing sheets

Instrumental in handling the complete resource management; ensuring the timely arrangement of resources. Being 2nd line to Head of Dept (Veeda Clinical Research), responsible for recruitment and line management of resources. Compiled, developed and trained a team of 22 clinical research professionals for execution of clinical development projects.

Demonstrated excellence in interacting with Sites, vendors and other stakeholders for Clinical Project

Therapeutic Area expertise: Oncology and Psychiatry. Hands on experience on Biosimilar development projects. Primarily worked on Phase III for such clinical development projects.

Optimized clinical development solutions by identifying and training resources on contract

Strategising resource oriented policies including appraisal policy, improvement programs, training schedules, troubleshoot protocols

Ability to improvise, assess complex problems; successfully developed and ramped-up fast practical solutions to meet immediate need in the processes.

Consistent success in maximising overall operational performance and handling relationship management as well as team management.

Core Competencies and Key Achievements

- Strategic Planning - Business Development - Key Account Management

- Clinical Operations - Project Management - New Set-up

- Relationship Management - Resource Management - Project Deliverables

- Budgeting - Promotional Activities - HR

- Clinical Research - Presentation - SOP Management

Career Contour

Mar ’18-Present Pharmacy Intern @ Shivaji Group Inc, Fl

Dispensing of medicines as per the order and regulatory requirement

Meeting patients and counsel them whenever needed

Interaction with patients on phone for their current and new medicines

Interaction with vendor and keeping track of product receipts and payments done

Reconciliation of medicines (ordered, dispensed, expired and balanced)

Interaction with doctor and his team for the clarification on prescription

Interaction with doctors and his team for the business development

Keeping documentation required in the pharmacy and managing archival of various documents including controlled

Feb ’15-Feb’18 Sr. Project Manager @ Veeda Clinical Research

Associated with Veeda Clinical Research Ltd as Project Manager in Clinical Operations and promoted. I was working on Phase II study on NSCLC/SCLC/Head & Neck/CHL. Accountable for all aspects of assigned clinical trials (Phase I/II/III) including leading cross-functional Clinical Trial Team(s) (CTT). Responsibilities included all aspects of study development including protocol and data review, site start-up, drug shipment logistics, enrollment, etc.

Contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions;

Collaborate with the Medical Team of the Veeda and investigators to ensure their feedback is adequately integrated into protocol.

Oversight of CRO staff including project management team, monitoring team, data management team and clinical research site staff

Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, safety updates, regulatory submission documents, responses to Health Authorities questions.

Develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings.

Lead protocol training meetings and support Clinical Operations Team in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s).

Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: report study progress and issues with their resolution plan.

Lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.

Forecast trial resources needs and accountable for the development, management and tracking of trial budget working

Accountable for accuracy of trial information in all trial databases and tracking systems.

Ensure that program specific standards (e.g., CRFs, outsourcing specifications including imaging, biomarkers PK, data monitoring, validation plans and data transfer specifications) are applied to the clinical trial, where applicable.

Contribute to the implementation of best practices and standards for trial management, including sharing lessons learned.

Successfully completed 4 clinical studies within time and budget.

Worked with apposite planning and transparency and hence became the preferred project manager for most clients.

Key member in developing service agreements and budget. Worked closely with business development for steering discussions with clients. Responsible for presenting on project execution plans with the clients for the start up inquiries.

Oct ’08-Jan '15 Lambda Therapeutic Research as Project Manager

Joined Lambda Therapeutic Research as Sr. Clinical Research Associate and got promotion in every alternate years. Rose to clinical team leader, Asso. Project manager and Project Manager. Responsible for the operational components of clinical trials. Responsibilities spanned the entire operational aspects of clinical trials from protocol and consent form development to study close out, and data management.

Created submissions packages including protocol development, ICF development, lab manuals, etc. for assigned clinical studies

Managed protocol submissions to the Steering Committee, Research Council and IRB including ancillary subcommittees

Managed and conducted pre-qualification visits, site initiation visits, and monitoring visits.

Reviewed major violations, deviations, SAEs, consenting issues prior to submitting to the required departments

Created resource allocation methodology through the use of MS Project which was implemented centre-wide

Developed and led governance meetings with major sponsors discussing topics such as queries, data, & audits

Led team meetings for each service which included trainings, compliance with FDA, GCP and QA regulations

Planning, Management and execution of biosimilar programs. Managed team training, presentation during Investigator Meeting and also, Site Initiation, Interim Monitoring and Site Close Out

Co-monitoring and training of team

Coordination between diverse departments: Coordinated between diverse stakeholders such as Medical and Safety Department, Biometrics Department, Project Management, IT and Business development.

oMedical and Safety Department: Regular coordination with Medical department for facilitation of response on medical query or protocol deviation/waiver for sites. Follow up and coordination between site and Medical department for Treatment Emergent AE, esp SAE

oData Management: Regular follow up with data management for query resolution on database especially during database lock. Coordinate with DM team for UAT and URS documentation during study start-up. Facilitate logistics and EDC and system access for site team.

Line management for employees and off-site and on-site training. Conducted approx. 15 co- monitoring visits

Involved in development of Clinical Trial Management System including Learning Management System

Budget and Proposal development

Made study drug administration easy and uniform for injectable products for the complex studies. Proficient in management of IMPs and completed projects with usage of least IMPs.

Dec ’06 - Sep ’08 Torrent, as Scientist II

Job Role

Conducting independent visits for carrying out the required site selection, initiation, monitoring, close out for oncology (Prostate and Head and Neck) Projects.

Performing site start-up activities

Executing the budget negotiations with sites; carrying out the training programs for the junior CRAs.

Coordinating with the customers and vendors involving site, translators, courier facility and travel agents for proper service.

Managing the efficient use of resources and ensuring the timely provision of project deliverables.

Developing new vendors and handling the budget preparation; management & negotiations for outsourcing of projects

Key Highlights

Instrumental in delivering presentation on ‘CRF Completion Guidelines’ during Investigator Meeting at Hyderabad.

Managed to attain distinction with highest enrolling sites in oncology projects (80% enrolment)

Jun ’06 – Dec ’06 Intas, as CRA

Roles and Responsibilities

Executing clinical trials through assigned sites; receiving trainings on team work, time management and communication.

Conducting site visits for site selection, initiation, monitoring and close out, primarily for respiratory trials.

Apart from this budget preparation and negotiations, drug packaging, asking quotations from CRO for project outsourcing, drafting SOPs and training colleagues on SOP.

Involved in Pharmacovigilance as a team member.

Key Highlights

Received appreciation and approval for site selection, site initiation and monitoring in first Accompanied Field Visit. Arranged and attended Investigator Meeting at Singapore.

IT Forte

Clinical Trial Management Software Simple CTMS, Informant

Pharmacovigilance Software : VINCURA

Data Management Software: Medidata Rave

Academia

2006 M.Pharm. (First Division) from Gujarat University, India

2003 MBA (First Division) from Gujarat University, India

2001 B.Pharm. (First Division) from North Gujarat University, India

ANNEXURE

Therapeutic Exposure

Therapeutic Area

Indication

Oncology

Breast cancer, Ovarian cancer, Renal cancer, Colon cancer, Brain cancer, NSCLC, NHL, Head & Neck cancer

Psychiatry

Schizophrenia, Depression

Kidney diseases

Hyperphosphataemia, Anaemia, fungal infection in CKD

Pain

Osteoarthritis Pain, Neuropathic Pain

Auto immune

Rheumatoid Arthritis, Atopic dermatitis

Implant

Avascular Necrosis

Ophthalmology

Wet Age related macular degeneration

Liver disease

Hepatitis B

Respiratory

COPD

Obesity

Obesity

REFERENCES

ON REQUEST



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