Partner Line Manager/Associate Director of Clinical Operations

NAIYA BHUPENDRA PATEL, B.S., CCRA

**********@*****.***

CURRENT ADDRESS:

***** **** ***

Gainesville, VA 20155

OBJECTIVE

To secure a challenging position in clinical research that utilizes my biology and public health knowledge in impacting the success and growth of a clinical research group.

EDUCATION

James Madison University, Harrisonburg, VA

Bachelor of Science in Biology and Health Sciences, Concentration in Public Health May 2007

Minor; Nutrition and Chemistry

TECHNICAL SKILLS

MS Word, MS Excel, MS PowerPoint, MS Access, WordPerfect 6.1, Windows XP, Adobe Acrobat Reader, Adobe Photoshop, Netscape Communicator

CLINICAL RESEARCH EXPERIENCES

PRA Health Sciences Jan 2017-Present

Senior Partner Line Manager/Associate Director of Clinical Management

Regional: Gainesville, VA

• Manage and develop PRA employees (CRAs and Managers) to ensure high quality work performance and retention of high quality employees.

Supervises and coordinates Clinical Management roles, including mentoring managers and employees in daily activities and responsibilities to the clinical deliverables.

Supports the clinical team to ensure they are provided the necessary support and resources to successfully deliver critical deliverables.

Manages clinical management resource levels including hiring and promoting, as appropriate. Participates in resource calls and ensure teams are provided with adequate levels of appropriately qualified resources

Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines.

Responsible for the management of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual expectations

Develops plans to support growth and career development of assigned Clinical Operations

employees as well as manage the delivery of quality performance in line with their job description.

Ensures staff development and performance feedback are provided through activities such as mentorship and career development

Communicates team and individual goals and expectations to ensure direct reports understand their responsibilities

Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.

Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.

Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed customer expectations.

May conduct assessment visits with clinical management staff as required by SOPs

Reviewing project tasks and timelines and assigning team members

Determines level and type of employee resources to meet corporate/client/project objectives

Schedules and reviews project tasks, provides leadership in the delivery of services to clients

Provides guidance/insight on aspects of clinical operations, as well as contingency planning, to accommodate projects while identifying potential impacts to the budget

Leading Clinical Operations employees in the delivery of services to clients

Ensuring staff fulfill their responsibilities in accordance with PRA’s policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements

Liaising with other functional managers to ensure consistency within the company

Liaising with other functional managers to ensure consistency within the company

Maintaining utilization of all Clinical Operations employees within department goals

Provides leadership and implement Clinical Operations services and productivity improvements to ensure optimal utilization of billable staff

Performing metric collection and data analysis to support PRA’s continuous improvement in

policies, procedures, and business process

Identifying and implementing process improvements through review of clinical operations SOPs, processes; recommending improvement plans to senior management.

Leading task forces to implement process improvement initiatives

Building teamwork and improving process and productivity by working within and across

functional areas

Be a point of escalation (internal) for resolution of issues and conflicts.

Evaluates compliance of assigned Clinical Operations employees with PRA systems and processes

Provides support with proposal development and participates in client presentations and/or bid defense meetings, as required

INC Research Mar 2015-Jan 2017

Clinical Project Manager/Line Manager

Regional: Fairfax, VA

Management of Trial and CRAs/CTLs on Project Level

Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines.

Supervises and Leads the study management team

Including oversight of CRO and vendors.

Trains new staff on the protocol and necessary processes. the training of staff involved in clinical trial management.

Provides training to clinical operations staff and performs performance appraisals of direct reports twice a year

Works with study start up in preparation and finalization of project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments

Coordinates with study start up on the selection of investigators and study sites

Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor

Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT

Works with CRAs and Data Management to ensure that CRF data queries are resolved

Responsible for the preparation of study budgets and timelines

Manage project timelines and vendor performance to meet departmental and corporate goals

Manage study budget and payment process for all clinical trial vendors including investigative sites

Monitor and track clinical trial progress and provide status update reports

Manages all trial vendors (IVRS, central labs, IRB, and central ECG)

Hire, train and oversee study field monitors (e.g., review of all trip reports) and provide guidance on site issues

Conducts Review of Trip Reports

Provides supervision in the planning of investigator meetings and making presentations, as required

Represent clinical operations at the project team level for individual studies, as appropriate

Identify and escalate site, vendor and study related issues to supervisor, as appropriate

Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner

Supervise clinical trial assistants and clinical research associates, and perform performance appraisals

Reviewing or approving of IP release packages

Managing investigational product (IP) accountability and reconciliation process

Tracking and reporting on progress of study including site activation, patient enrollment, monitoring visits

Reviewing key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team

Responsible for the management of operational team deliverables to customers, including the management of study timelines and ensuring adherence to the contracted scope of services

Implementation and management of full service clinical studies

Performs ongoing review of project financial status of studies; alerts senior management to potential issues and ensures necessary corrective action is taken.

Accountable for and facilitates contact between multidisciplinary project teams and customers, including vendors (domestic and global)

Management of study and operational team communication to ensure cost efficiencies, study goals and objectives are met

Ensure all internal and external quality standards, SOPs, GCPs, and ICH guidelines are maintained in accordance with all local, state, and federal regulations.

Manages the development of study documents, project plans, and study tools through all study phases

Develops and conducts study specific project team training

Coordinates site management activities

Coordinates and presents at Investigator and face-to-face customer meetings

Participates in Business Development client presentations and bid defenses

Responsible for independently determining methods and procedures on new assignments and provides guidance and supervision over the activities of direct report personnel

Participates in PM mentor program

Provided oversight and management of investigator grants and site invoices for a large Phase III program

Responsible for management of 10 CRA/CTA/CTLs direct reports

Develop Training Plans

Complete mid-year and annual reviews

Conduct 1:1 meetings to provide feedback and support

Ensure training plan is completed per company policies

Coordinate with resourcing to place direct reports

Monitor and evaluate CRA/CTA workloads to ensure appropriate allocation of resources is utilized

Quintiles Mar 2012-Feb 2015

Clinical Associate Project Manager/Line Manager

Regional: Fairfax, VA

Responsible for the supervision and administrative oversight of 10 CRA direct reports

Develop training plan

Ensure CRA metrics are met

Implement individual development and provide coaching and mentoring to assigned CRA

Evaluate strengths and opportunities for growth/Sets objectives and goals for the year

Complete mid-year and annual reviews

Have regular 1:1 monthly meetings to provide support and feedback

Monitor and evaluate CRA workloads and liaise with Resource Management, the relevant Project Manager and Director of Clinical Operations (as needed) to ensure appropriate allocation of resources and optimal utilization and workload

Conduct on-site Monitor Assessment Visits as required

Review/approve CRA expense reports and timesheets

Collaborate with resourcing for project specific needs/demands

Responsible for management of 12 CRAs at a project level;

Oversee the monitoring of the clinical study to assure adherence to protocol, GCP, FDA regulations and overall clinical objectives including study prequalification, initiation, interim and close-out visits;

Train contract and in-house CRAs on study protocols, study procedures, and monitoring SOPs;

Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, quality standards and expectations per Contract

May conduct site monitoring visits for a variety of protocols, sites and therapeutic areas

Provide input, updates to the Clinical Project Manager regarding the monitoring status and CRA team progress and deliverables.

Vendor Management

Assist CPM with study start up procedures, logistics, document preparation, and site selection

Provide input to line managers on their project team members’ performance relative to study tasks.

Conduct co-monitoring visits to manage data backlog, site compliance and quality issues, may be beyond home geography.

Act as site visit report reviewer

May take on special project assignments related to function/corporate initiatives.

Create FAQ Log

Create, track and report on project timelines.

Produce and distribute status, tracking and financial reports for internal and external team members and senior management.

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

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

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

Coordinate data gathering for the development of proposals for new work.

Prepare and present project information at internal and external meetings.

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

Undertake clinical project management activities as directed by Clinical Project Manager.

Train and may coordinate the work of more junior project support staff.

May provide direct site support (on site visits)

Quintiles Sep 2011-Mar 2012

Sr. CRA/Lead CRA

Regional: Fairfax, VA

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice

Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations

Escalate quality issues to Clinical Team Lead (CTL) and/or Line manager (LM).

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation

Act as a mentor for clinical staff including conducting co-monitoring and training visits

Provide assistance to the CTL with design of study tools, documents and processes

Assist in mentoring and training of junior clinical team members to promote a strong team approach

PRA International Feb 2010-Sep 2011

Sr. Clinical Research Associate

Regional: Arlington, VA

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines

oVisits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies

oProvides regular clinical status information to team members and project management

oPerforms billable work in accordance with PRA policies, procedures, and Standard Operating Procedures (SOPs)

oWorks closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff

oCommunicates common site trends to Lead CRA and other project team members

Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements

oPerforms source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites

oEnsures Serious Adverse Event (SAE) reporting according to project specifications

oResponds to requests from investigative sites in a timely fashion

CROfessionals, LLC, Warrenton, VA March 2008-Feb 2010

Clinical Research Associate III

Participate in protocol and CRF development

Conduct basic clinical trial study monitoring activities, under supervision of a Project Manager to include:

Ensuring regulatory and protocol compliance of investigator site

Coordinating Sponsor’s communications with sites to ensure investigators’ responsibilities

Management of investigative site under supervision of a Project Manager

Overseeing investigator management to ensure consistency across sites, and to minimize problems such as protocol deviations/violations

Initiate routine payments to clinical sites

Assist with drug shipment to clinical sites as defined per project

Review, understand and comply with Clinical Research SOPs

Prepare correspondence and study documentation wit h appropriate archival of electronic and paper copies

Review initial data listings against CRFs

Assist with preparation of documents for regulatory submission, such as typing parts of reports, tables

Assist with drafting of Annual Reports

Qualify Investigators

Make presentations to Investigators

Organize Investigator Meetings

Prepare regulatory document binder for sites and Investigator Files

Ensure the binder is up to date with the appropriate documents

Emmes Corporation, Rockville, MD May 2007-March 2008

Clinical Research Associate I

Assisted the team in reviewing proposed scientific protocols

Developed electronic case report forms, supporting documents, such as the Manual of Operations, for clinical sites to refer to for questions

Traveled to clinical sites to monitor site activity

Tested data system before making it available to NIH clinical sites

Trained the clinical sites on the use of the data system

Monitored the data system as data accrue to ensure data integrity

Prepared, submit, and manage administrative and regulatory documents for the Herpes Study

Assisted new clinical protocols for IRB submission

Coordinated, submit, and monitor IRB regulatory documents for clinical trials and assisted with subsequent data monitoring including completing queries generated by Sponsors

TRAINING AND CERTIFICATION

NIH GCP Certification Mar 2011

Barnett GCP Certification Mar 2016

ACRP CCRA Certification Mar 2016

Pursuing PMP

CLINICAL TRIAL EXPERIENCE

NEUROLOGY

oParkinson’s Disease-Phase III

oMultiple Sclerosis-Phase III

oAlzheimer’s Disease-Phase II, III

oMigraine-Phase III

oEpilepsy-Phase II

PSYCHIATRY

oMajor Depressive Disorder-Phase III

oBipolar-Phase III

oSchizophrenia-Phase I, III

ONCOLOGY

oBreast Cancer-Phase III

oOvarian Cancer-Phase III

oLung Cancer-Phase III

oTumors-Phase III

IMMUNOLOGY

oIdiopathic Thrombocytopenia-Phase III

oHemophilia-Phase IV

DERMATOLOGY

oPsoriasis-Phase III

oEczema-Phase III

OPTHAMOLOGY

oGlaucoma

oRetina

*References available upon request

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