Pratik Rele Email & Phone Number

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Founded a great new chapter of a fraternity called Beta Gamma Nu which helps students to get through college by motivating them, guiding them through different learning process, teaching them leadership skills and much more. We maintain a strict GPA policy which makes all our members excel not only in sports but also in academics.

Thousand Oaks, Ca, Us

Strategic and Operational lead for Publications and Medical Communications

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

• Lead four different workstreams and teams in DM to reduce the time and resources used for study database setup and its maintenance. The goal is to make the database build process the most efficient in the industry.• Conduct industry survey and communicate with different vendors to review the out of the box solutions.• Collaborate with the ‘Standards’ team to develop processes for creating new standards and their uptake into the study.• Oversee the implement technologies like ALS and Repositories to help reduce the time taken for database build and reduce redundant testing.• Create a new process to automate DMP and also reduce programming of Edit Check, Custom Function and Derivations.• Introduce a new structure for creating Spotfire visualizations for data cleaning and LLR review.• Work with compliance teams to validate the processes and handle documentation updates with help of sub-team members.• Write and Review SOPs, MANs and other training and instruction documents.• Lead discussions with vendors on resource algorithm changes and also manage internal resourcing need by calculating the savings based on the new processes.

Thousand Oaks, Ca, Us

• Maintain a working relationship with Medidata and participate in FMTs/OMTs.• Review new RAVE releases and manage patches to upgrade current RAVE version to the latest by mitigating any risks to the current on-going studies.• Provide guidance on issue resolution and creation of scripts.• Handle operations of the ticketing system and generate reports to help ensure the number of open issues is minimal or escalate them to Medidata for resolution.

Thousand Oaks, Ca, Us

• Work closely with the study teams to help capture the specifications for eCOA/ePRO assessment in the protocol.• Work with Global Health Economics (GHE) to discuss the need for any equivalence study based on the format of the assessment selected in the protocol.• Manage the licenses with the assessment authors and allocate budget based on the needs of the study.• Review the protocol and send our Request for Proposals (RFPs) to different eCOA/ePRO vendors.• Manage and Lead the RFP process and related discussions with study teams and assign awards to the vendor.• Provide technical expertise for finalizing the specifications and working of the devices.• Oversee data integrations of systems like IxRS, eCOA/ePRO with EDC systems.• Manage timelines for the implementation, delivery and issue resolution of the devices in the study.

Thousand Oaks, Ca, Us

- Lead 20+ teams on product basis (including FIH, medical devices, Early Dev, General Med, Oncology studies) to have a timely project delivery on all stages of the trial (study start up, conduct, maintenance, final lock, snapshots, analysis timelines, and closure).- Act as a Technical Specialist/SME to provide guidance to the Study Designers, CDAs and Project Leads during the study build or conduct by providing inputs on the company/industry standards and intricate study protocols build questions in a CRO or outsourced setup.- Alliance with different teams and departments for finalizing various components of the trial (Data Acquisition, Statistical Programming, Biostatistics, Study Management, Site Management, Protocol writers, UAT teams, IS).- Assist in resource planning and allocation by collaborating with the partners.- Prepare timelines for study build and milestones and align systems to be ready for the build.- Be a gateway for quality control during build, migrations, snapshots and locks.- Perform Script Utility for the trials when needed.- Hold FMTs, vendor evaluation and status update meetings with Medidata (or any other vendor as needed) especially for the pending Work Requests and escalations.- Lead initiatives like JIRA, eSAE and define strategies for process improvement and increase efficiency to optimize the time and resource constraints in the cycle.

Deerfield, Illinois, Us

- Assist in reviewing DMP, CRF design, and other CDM documents.- Perform CRF SDTM annotation and CDISC controlled terminology management.- Conduct SDTM programming and documentation for regulatory submissions.- Assist in the preparation of the regulatory submission – ready packages.- Create SAS listings for data review based on the needs of the trial.- Develop and maintain working relationships within and outside of CDM (ESPs) at the program level for DDE – related tasks.- Review, verify or validate work performed by the peers and external service providers.- Co-ordinate with different teams (internal/external) to meet program level deliverables.

Thousand Oaks, Ca, Us

During the process of finalizing the protocol for any Clinical Trial, I have to assign the naming conventions for each event in the trial. Based on these naming conventions, folders are prepared in RAVE and other systems will also follow these naming conventions to avoid confusion and have a uniformity inturn reducing time and effort.

Thousand Oaks, Ca, Us

Working as a SAS programmer with the Metrics and Reporting team at Amgen.The job responsibilities include: - Writing SAS programs - Running reports depending on needs - Modifying reports - Documentation for Business

Thousand Oaks, Ca, Us

Leading the project for a Forecasting Tool Developed by Amgen for Tracking and Forecasting Clinical Trials Samples and Part of Study Event Naming Standardization Team.Major Responsibilities: - Setting up Clinical Trials in Forecasting Tool - Troubleshooting the Tool - Link between the business and the users of the Tool - Documentation for the project - Supervising Clinical Trial Naming Standardization

San Diego, Ca, Us

Working as a data analyst and SAS programmer for Dr. Xundong An who is a Professor in the Finance Department, SDSU. My basic role is of an Analyst and a programmer working on Home Mortgage Disclosure Act data since 1995.

Ms, Biostatistics

Msc, Statistics