Ajay Teki
Toronto
Summary
Experienced Clinical Data Lead with a robust skill set in all facets of clinical data management. Proficient in study setup, database design, data validation, query management, coding, and reconciliation. Well-versed in CDISC standards (SDTM and ADaM) and adept at utilizing clinical data management systems like Medidata Rave and Oracle Inform. Proven leader with the ability to mentor teams, providing guidance for successful project execution. In-depth knowledge of FDA and ICH guidelines ensuring compliance in clinical data management. Exceptional written and verbal communication skills to facilitate collaboration with cross-functional teams, investigators, and vendors. Detail-oriented and quality-focused, excelling in project management within established timelines and budgets. Strong leadership and interpersonal skills effectively contributing to project success.
Overview
12
12
years of professional experience
Work History
DATA TEAM LEAD
IQVIA
04.2024 - Current
- Led and managed a team of over 04 clinical data managers, providing hands-on guidance, training, and support to ensure the production of high-quality deliverables.
- Collaborated with cross-functional teams, including biostatistics, clinical operations, and medical team ensuring a seamless flow of data throughout the project lifecycle.
- Conducted comprehensive risk assessments and developed effective risk mitigation strategies to address data quality and integrity issues, ensuring the reliability of clinical trial data.
- Ensured strict compliance with regulatory guidelines and internal standard operating procedures, leading database design and build activities while adhering to CDISC standards and data collection best practices.
- Monitored and tracked study timelines, proactively identifying and resolving potential delays or bottlenecks to maintain project schedules and milestones.
- Coordinated with external vendors, such as central laboratories and electronic data capture providers, to ensure smooth data transfer and integration, contributing to the overall success of clinical trials.
- Conducted and led weekly metrics-driven meetings with sponsors and clinical teams, providing a platform for discussion, issue resolution, and transparent communication.
- Actively participated in global cross-functional meetings on a weekly basis, presenting data management metrics and achievements, discussing identified risks, and providing resolutions for effective project management.
- Contributed to the development and continuous improvement of data management processes, standard operating procedures (SOPs), and training materials, ensuring the optimization of workflows and adherence to industry best practices.
- Engaged in the submission of essential documents through the Vendor Trial Master File (VTMF) process, utilizing a structured TMF filing matrix. Responsible for the meticulous filing and organization of critical study documents, ensuring compliance with regulatory requirements and contributing to the maintenance of a well-structured Trial Master File.
- Actively participated in discussions related to project timelines and budgets, playing a key role in updating timelines and obtaining approvals for existing budgets through the change order process. Successfully ensured alignment with project goals and financial parameters.
CLINICAL DATA SCIENCE LEAD
ICON PLC
11.2020 - 03.2024
- Led a team of 10+ clinical data managers, offering guidance, training, and support to deliver high-quality results.
- Oversaw the entire data lifecycle for clinical trials, from study setup to database lock, ensuring compliance with regulatory standards.
- Collaborated with cross-functional teams to ensure efficient data flow across all stages of the project.
- Performed risk assessments and implemented mitigation plans to safeguard data quality and integrity.
- Ensured adherence to regulatory requirements and internal SOPs, guiding database design in line with CDISC standards.
- Managed study timelines and proactively addressed potential delays to keep projects on track.
- Coordinated with external vendors for seamless data transfer and integration.
- Led weekly metrics meetings with sponsors and clinical teams to address issues and ensure clear communication.
- Participated in global cross-functional meetings to present data metrics and address project risks.
- Contributed to the development of data management processes, SOPs, and training materials.
- Managed document submissions via the Vendor Trial Master File (VTMF) process to ensure compliance.
- Participated in timeline and budget discussions to align project objectives with financial goals.
SENIOR CLINICAL DATA MANAGER
PFIZER INDIA PVT.LTD
08.2018 - 10.2020
- Conducted all-encompassing clinical data management activities for assigned clinical trials, ensuring meticulous attention to detail and adherence to industry standards.
- Developed and meticulously maintained data management plans and associated documentation, providing a structured framework for efficient data handling throughout the trials.
- Spearheaded the creation and maintenance of study databases, encompassing database design, data entry screens, edit checks, and data validation rules, ensuring data accuracy and integrity.
- Executed ongoing data review, query management, and resolution of data discrepancies, fostering a proactive approach to maintaining data quality throughout the clinical trial process.
- Prepared and executed data transfer agreements with external vendors, managing the intricacies of data transfer processes for seamless collaboration and information exchange.
- Conducted comprehensive user acceptance testing for electronic data capture systems, ensuring optimal functionality and usability for streamlined data collection.
- Planned and managed resources for assigned studies, optimizing resource allocation for efficient study execution and meeting project milestones.
- Acted as the primary point of contact for sponsors, providing regular updates on data management activities, timelines, and deliverables, fostering transparent communication and stakeholder satisfaction.
- Conducted training sessions for team members, ensuring proficiency in new processes, technologies, and industry best practices, contributing to a skilled and knowledgeable team.
CLINICAL DATA COORDINATOR II
ICON INDIA PVT. LTD
06.2017 - 07.2018
- Spearheaded the management of data cleaning and query resolution activities, ensuring the timely and accurate delivery of data. Implemented robust processes to streamline data cleaning, leading to enhanced data quality and integrity.
- Conducted regular meetings with team members, providing guidance, monitoring progress, and addressing challenges or issues. Focused on fostering effective communication within the team, resulting in improved collaboration and streamlined workflows.
- Acted as the primary point of contact for sponsors, delivering regular updates on data management activities, timelines, and deliverables. Maintained a transparent and responsive communication channel with sponsors, ensuring their confidence in the data management process.
- Participated in study team meetings, contributing valuable insights on data management-related issues and proposing effective solutions. Played a pivotal role in collaborative decision-making, aligning data management strategies with overall study objectives.
- Conducted meticulous quality control checks on study documents, data listings, and reports, ensuring adherence to established standards and guidelines. Implemented rigorous quality assurance measures, contributing to the production of high-quality, error-free deliverables.
- These experiences collectively showcase a comprehensive skill set in managing data processes, fostering team collaboration, maintaining effective sponsor relations, actively contributing to study team dynamics, and ensuring the highest standards of quality control in data management activities.
CLINICAL DATA COORDINATOR
Quintiles India Pvt. Limited
03.2016 - 06.2017
- Led multiple projects as a Data Operations Coordinator, demonstrating a proven track record of successfully managing complex clinical data management initiatives.
- Managed all facets of clinical data management for assigned studies, from database set-up and data cleaning to database lock activities. Ensured meticulous attention to detail and adherence to industry standards throughout the data management life cycle.
- Developed and implemented robust data management plans and data validation specifications, providing a structured framework for efficient and accurate data handling.
- Conducted thorough data review and query management to ensure data accuracy and consistency, employing proactive strategies for timely resolution of queries and discrepancies.
- Collaborated closely with cross-functional teams to resolve data discrepancies and facilitate timely query resolution. Contributed valuable insights to ensure seamless data flow and adherence to data management processes.
- Worked collaboratively with external vendors and study sites to ensure smooth data flow, fostering strong partnerships and adherence to data management best practices.
- Participated in study team meetings, providing valuable input on data management-related issues and proposing effective solutions. Actively contributed to collaborative decision-making within the study team.
- Generated and distributed study-specific data listings, reports, and summaries for internal and external stakeholders, ensuring transparent communication and facilitating informed decision-making.
- Conducted thorough quality control checks on study documents, data listings, and reports, maintaining a high standard of quality assurance throughout the data management process.
JUNIOR DATA ANALYST
COGNIZANT TECHNOLOGY SOLUTIONS
06.2013 - 03.2016
- Coordinated and meticulously oversaw data management activities for multiple clinical trials. Managed data collection, cleaning, and reconciliation processes, ensuring the seamless flow of high-quality data throughout the trails.
- Conducted thorough reviews of clinical trial protocols, case report forms (CRFs), and electronic data capture (EDC) systems. Ensured data quality and integrity by scrutinizing study documentation, implementing rigorous quality control measures.
- Successfully developed and implemented comprehensive data management plans, ensuring strict alignment with study protocols and regulatory guidelines. Meticulously designed plans to facilitate efficient and accurate data handling throughout clinical trials.
- Conducted meticulous data validation checks, proactively resolving data discrepancies, and implementing corrective actions as necessary. Ensured the accuracy and reliability of clinical trial data through vigilant monitoring and resolution processes.
- Collaborated effectively with cross-functional teams, including clinical operations, biostatistics, and medical affairs. Defined data collection and reporting requirements, fostering alignment with study objectives and regulatory standards.
- Stayed up to date with emerging trends and advancements in clinical data management practices. Actively contributed to process improvement initiatives by incorporating the latest industry best practices into data management strategies.
Education
Bachelor of Pharmacy -
MAHARAJAH'S COLLEGE OF PHARMACY, ANDHRA UNIVERSITY
04.2012
PG Diploma - Computer Applications
Andhra University
06.2019
Skills
- Leadership
- Problem Solving
- Clinical Data Management
- Time Management
- Risk Assessment and Mitigation
- Project Management
- Critical Thinking
- Effective Communication
- Interpersonal skills
- Training and Mentoring
- Adaptability and Flexibility
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Telugu
Native or Bilingual
Tamil
Full Professional
Hobbies and Interests
Fitness Enthusiast, Cycling
Details
- 550 Jarvis Street, Toronto, M4Y 2H9, Canada, +1 (647) 572-0188
- Ajay.teki19@gmail.com
Links
www.linkedin.com/in/ajay-teki-9bb928b4
Timeline
DATA TEAM LEAD
IQVIA
04.2024 - Current
CLINICAL DATA SCIENCE LEAD
ICON PLC
11.2020 - 03.2024
SENIOR CLINICAL DATA MANAGER
PFIZER INDIA PVT.LTD
08.2018 - 10.2020
CLINICAL DATA COORDINATOR II
ICON INDIA PVT. LTD
06.2017 - 07.2018
CLINICAL DATA COORDINATOR
Quintiles India Pvt. Limited
03.2016 - 06.2017
JUNIOR DATA ANALYST
COGNIZANT TECHNOLOGY SOLUTIONS
06.2013 - 03.2016
PG Diploma - Computer Applications
Andhra University
Bachelor of Pharmacy -
MAHARAJAH'S COLLEGE OF PHARMACY, ANDHRA UNIVERSITY
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