Hemlata Petkar

Roles and responsibilities

• Serve as 1st point of contact for any concerns or challenges or escalation.
• Find out the risk and inform stakeholders. Share mitigation plan for risk identified.
• Ensure compliance to SOP and training.
• Resource Management
• Budget management
• Ensure all DM activities from set up to conduct are well managed and meet as per planned timelines.
• Provide status updates to client.

Achievements:

• Achieved clients confidence by demonstrating positive attitude to rescue multiple challenges.
• Receive 10 appreciations in last year.
• Have turn the table for many escalation and received applaud from client.
• Provided end to end technical support and troubleshooting for Study Data Manager and Clinical Data Reviewer.
• Assisted customers with training on how to use the InForm and Veeva databases.
• Configured eDC specifications and set up eDC systems within Upper quartile targets.
• Performed data analysis and created reports to identify trends or discrepancies in the data.
• Identified issues, and provided solutions for improvement.
• Automated manual processes related to data validation tasks.
• Collaborated with stakeholders on requirements gathering, design, development, testing, and implementation of new databases.
• Resolved complex queries by analyzing eCRF data.
• During set up evaluated current database structures and recommended improvements based on best practices.
• Maintained relationships with external vendors providing services related to database management.
• Resolved information access issues, troubleshooting to improve customer and internal data entry and access.
• Maintained knowledge of advances in information technology systems and applications.

Roles and responsibilities:

• Assist in recruitment and selection of team member. Ensures maximum reuse of Standards so consistency maintains across TA's.
• Review and provide inputs to the training materials.
• Provide inputs to roles and responsibilities documents or any equivalent document in
• collaboration with project whenever required.
• Share process updates in timely manner.
• Maintain regular connects with client to seek feedback for data managers performance and if any concerns.
• Follow escalation channel, highlight potential study risk to Project managers.
• Support data mangers to be inspection ready at all times to support audit and compliance requirements
• Provide regular status reports on budget recognition to Project managers and ensure timely

Achievements:

• Followed comprehensive mentoring program to support new employees in their transition into the company.
• Monitored and evaluated mentees' progress, providing feedback and guidance to ensure success.
• Mentored individuals on professional development topics such as communication skills, problem-solving and goal setting.
• Conducted regular one-on-one meetings with each mentee to discuss challenges, successes and goals.
• Provided advice to mentees on career paths, job opportunities and educational options.
• Facilitated group activities for mentors and mentees to build relationships and foster collaboration.
• Encouraged open dialogue between mentor and mentee pairs to promote trust, respect and understanding of different perspectives.
• Organized team building events that enhanced team morale and improved working relationships among colleagues.
• Maintained up-to-date records of mentor and mentee interactions in order to track progress over time.

Roles and responsibilities

• Review study Protocols and share inputs to Protocol, eCRF screens to ensure it is fit for purpose and add validation checks, create and/or provide inputs to study set up, conduct and close out documents.
• Drives discussion for development of electronic CRF/Vendor specifications.
• Attend screen review meetings where applicable, User Acceptance Testing (UAT), consolidate feedback and ensure appropriate Cascade and action.
• Ensure clinical data within eCRF meets quality defined in Follow DMP to ensure clinical data meets quality and lock and freeze forms for final or for interim milestones.
• Perform post Database Release (DBR) activities as required based on discussions/agreements with client, archival of relevant study documents to eTMF as appropriate.
• Proven ability to manage and communicate effectively with all stakeholders.
• ability to manage multiple studies. Serve as primary customer contact to establish project deliverables, schedules, and tracking mechanisms.
• Lead and conduct all end to end DM activities (set up, conduct, and closeout) required for global clinical trials. Perform project management, CRF design, independent review of CDM deliverables,
• Creating eCRF guidelines, edit checks, discrepancy management, post production change requests,newsletters to sites, Memo etc..
• Track project progress and issue status report.
• Performance management, training, and resource allocations in daily activities .Training and supervising Clinical Data Managers.
• Be responsible for identification of data handling processes for non-CRF data, including lab data,questionnaire data and image handling.
• Responsible for ensuring the integrity of data and providing recommendations for corrective action when necessary.
• Liaise with Biostatisticians regarding data validation and lock of the database, including management
• Evaluate immediate business impact and takes decisive action. Ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve.
• Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making.

• Processed specimens following established protocols while adhering to strict safety standards.
• Resolved customer complaints relating to laboratory services in a timely manner.
• Performed laboratory tests such as culture, ELISA etc.
• Maintained laboratory equipment by performing calibration checks and troubleshooting any malfunctions.
• Prepared solutions of reagents for use in experiments according to standard procedures.
• Conducted quality control testing on incoming materials to ensure accuracy of results.
• Collected samples from various sources for analysis in accordance with established guidelines.
• Managed inventory levels by ordering supplies and ensuring stock is available when needed.
• Maintained detailed records of test results for review by supervisors or other personnel as required.
• Assisted with training new lab technicians on proper operation of instruments, safety protocols, and other relevant topics.
• Ensured that all laboratory areas were kept clean and orderly at all times.
• Performed routine maintenance tasks such as cleaning glassware, changing filters.
• Identified potential problems during testing process and took corrective action as necessary.
• Collected, labeled and stored lab samples according to laboratory specifications.
• Completed lab tests and communicated results to supervising staff.
• Prepared test samples and obtained and recorded test data in accordance with standards.
• Maintained, calibrated and troubleshot pH probes, EC meters, balances, automatic pipettes and diluters.
• Assisted and instructed other laboratory technicians.
• Supervised cleaning and maintenance of laboratory equipment to prevent errors and breakdowns.

• Conducted daily laboratory maintenance, including cleaning and organizing.
• Performed quality control tests on incoming and outgoing materials to ensure safety standards were met.
• Monitored and maintained laboratory equipment such as pipettes, centrifuges, and microscopes.
• Prepared samples for analysis by weighing, filtering, or diluting them as needed.
• Recorded data from experiments into detailed lab reports for review by supervisors.
• Collected specimens from patients for testing in the laboratory setting.
• Followed strict safety protocols while handling hazardous materials in the laboratory environment.
• Maintained accurate inventory records of all chemicals used in experiments or stored in the lab.
• Calibrated laboratory instruments according to manufacturer's specifications.
• Provided technical guidance and training to new lab technicians.
• Implemented preventive measures against contamination of samples during testing procedures.
• Collected, labeled and stored lab samples according to laboratory specifications.
• Used time management and adaptability skills to prioritize and run multiple tests.
• Disposed of laboratory materials and samples using well established guidelines and instructions.
• Prepared specimens and forms for transport to outside laboratories.
• Supported cleanliness and health standards to foster safe and effective sample analysis.

• Greeted and welcomed customers in a friendly manner.
• Answered incoming calls and provided information about services and products.
• Scheduled appointments for clients and customers.
• Handled cash transactions accurately and efficiently.
• Managed bookings of conference rooms or other facilities.
• Provided administrative support to staff members.
• Maintained an accurate inventory of office supplies.
• Ensured that all areas of the front desk were kept clean and organized.
• Resolved customer complaints in a professional manner.
• Performed data entry tasks into computer systems as needed.

• Assisted in the preparation of reagents and solutions for laboratory experiments.
• Analyzed metal samples using a variety of analytical techniques.
• Conducted physical property measurements including pH, viscosity, and density.
• Maintained accurate records of test results and data analysis activities.