Varsha Aithal
Hannover
Summary
Experienced Clinical Data Management professional with 16+ years in the field, specializing in leadership roles and challenging environments. Possessing 17.5 years of total experience, including Line Management and Project Management. Results-oriented with expertise in Project management, resource management, and Risk Management. Deep knowledge of Clinical research and Data management processes to support clinical data coordinators and leads for project success. Skilled in managing large teams and high-priority studies simultaneously. Strong in customer relations, problem-solving, and employee training. Leading training initiatives for new employees with strong communication skills and attention to detail to ensure data quality standards for regulatory reporting.
Overview
20
20
years of professional experience
Work History
Senior CDM PM, CDM
PPD Part of Thermofisher PVT LTD
06.2023 - Current
- Manages day-to-day operations for a group of data management projects or key functions.
- May perform the Project Lead role for studies that do not have a clinical component or act as Franchise Manager for allocated clients.
- Provides customer contract and functional, administrative, and financial oversight.
- Monitors entire project life cycle to ensure smoothness (i.e., creation of edit checks, development of DM Listings, DB go-live, 3rd party vendor data and SAE reconciliation, DB Lock, timelines etc.).
- May act as the 'Account' Manager/CDM Franchise Lead for a portfolio of projects from one or more clients to provide oversight and ensure all tasks are completed accurately, on time and within budget to meet or exceed client expectations.
- Acts as primary liaison for project team and client.
- Participates in internal or client meetings as needed.
- Oversees risk management for projects/portfolios ensuring adherence to guidelines and process; provides ongoing support and guidance on assessment of project risks to the project members; provides/escalates high-level sharing of risks, concerns, and study success.
- Participates in business development meetings/activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required.
- Helps develop client relationships with oversight from management.
- Participates in the formation and implementation of strategic department development plans and initiatives.
- Oversees, reviews, approves the study documents (e.g., DVM) with input from the internal/client teams.
- Ensures development and maintenance of Data Management project documentation files (e.g., eTMF ongoing reviews) to maintain audit readiness at all times.
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
Senior Manager, CDM
Pharmaceutical Product Development
04.2020 - 05.2023
- Managed project staff and workload of direct reports.
- Was responsible for resourcing and administrative oversight of assigned projects as well as training, mentoring, and guiding project staff, direct reports.
- Provided training and mentoring to junior managers.
- Managed staff, which included interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
- Approved courses of action on salary administration, hiring, corrective action, and terminations.
- Reviewed and approved time records, expense reports, requests for leave, and overtime.
- Ensured staff compliance with documented procedures.
- Participated in business development activities including timely input to budgets and proposals for data management activities and presenting data management strategy at bid defense meetings.
- Participated in the formation and implementation of strategic department development plans and initiatives.
- Assisted senior management with the formation and implementation of strategic development plans for the department.
- Managed resourcing (allocations) for all assigned staff within DM portfolio, includes global resourcing reporting.
- Provided strong leadership to enhance team productivity and morale.
- Led cross-functional teams to achieve project milestones and deliver high-quality results.
Manager, CDM
Pharmaceutical Product Development
08.2017 - 03.2020
- Managing customer deliverables and handling 17 direct reports globally and has experience of handling 30 reports.
- Contributes to the operational strategy for the CDM group in support of overarching departmental strategy.
- Accountable to meet portfolio deliverables through project, resource and operational management deliverables including effective risk mitigation, resource planning, vendor management, implementation of technology solutions and cross functional communications.
- Served as lead for TPV reconciliations for the studies and as an SME for TPV reconciliations.
- Identify out-of-scope work and provide revised costs with supporting documentation.
- Participates in the development and implementation of processes, procedures, and training for the data management function.
- Assess and document competency of staff to satisfy position responsibilities.
- Regularly set goals and evaluates and document performance.
- Propose salaries, promotion, and termination actions.
- Lead and motivate the group according to organizational goals.
- Performs ongoing performance appraisals and supports staff development for direct reports.
- Supports HR and DM management with the hiring, discipline, and discharge of staff as necessary.
- Identify and address professional development/training needs of staff.
- Manage staff in accordance with organization’s policies and applicable regulations.
- Involved in resource management group and involved in assessing the study requirement and assigning employees the projects globally.
- Ensure project milestones are met according to agreed timelines.
- Actively manage quality throughout project.
- Monitors entire project life cycle to ensure smoothness (i.e., creation of edit checks, development of DM Listings, DB go-live, 3rd party vendor data and SAE reconciliation, DB Lock, timelines etc.).
- Act as primary liaison for project team and client.
- Participates in internal or client meetings as needed.
- Ensures development and maintenance of Data Management project documentation files (e.g., eTMF ongoing reviews) to maintain audit readiness at all times.
- Moved to Germany as Remote role in 2021 October.
Manager, CDM
inVentiv International Pharma Services Private Ltd
04.2016 - 08.2017
- Managing customer deliverables and handling 19 direct reports since Dec 2014.
- Serve as SME for Local Lab and Central Lab data handling and leading complex studies.
- Planning for meeting timelines and quality criteria, risk management and mitigation, process enhancements and mentoring of new hires.
- Provide inputs to business development presentations.
- Validating the completeness, accuracy and consistency of the clinical trial database on an ongoing basis.
- Perform comprehensive quality control procedures for lab data management activities.
- Mentor other team members and lead data managers in training and developing data management expertise.
- Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
- Involved in resource planning for the project and training, i.e. allocation of resources to projects/tasks by ensuring assignments are appropriate to staff experience and training and ensure the tasks are completed within the deliverable.
- Tracking realization of the project and analyzing utilization of study team members.
- Communicates with both internal and external customers to ensure that timelines are met, and to ensure that data is delivered following sponsor guidelines and regulatory compliance.
- Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and financial aspects.
- Participate in appraisal cycle and provide feedback to the employee.
- Guiding professional development and rewarding employees as per organization policies & regulations.
- Addressing employee relations issues and resolving problems as per organization regulations and policies.
- Involved in interview and onboarding of candidates.
- Solve issues through using the issue escalation/communication plan.
- Understand and comply with core operating procedures and working instructions and meet objectives as assigned.
- Develop and maintain good communications and working relationships with team both on shore and offshore.
External Lab Data Manager
Accenture Services Pvt Ltd
02.2007 - 03.2011
- Ensure the completeness and accuracy of Clinical Lab data in the Clinical database.
- Good understanding about reporting of lab data- Local and central labs.
- Review and resolve data discrepancies identified by the system or through manual checks as identified in the data editing guidelines.
- Review and edit laboratory data, which has been loaded as well as the reference information that support eCRF/pCRF laboratory data.
- Perform Oracle Clinical Laboratory Assignment Criteria (LAC) function for the assignment of lab site id’s to laboratory and also assign standard test codes.
- Review and edit traditional eECG data which is loaded (Tracking).
QC Microbiologist
Tetragon Chemie Pvt Ltd
09.2005 - 02.2007
- Responsible for analysis of the products before releasing it to the market.
- Responsible for the validation of drugs.
- Responsible for validation and calibration of instruments and products.
- Implementation of guidelines and quality system prescribed by management for managing practices.
- Analysis of vendor raw material samples with the customer requirements.
- Conducted clinical trials for various drugs.
- Implementation of ISO, 5S and HACCP manuals for quality improvement.
- Checking of personal hygiene and maintaining of personal hygiene in the company.
Education
Master of Science - Microbiology
M.S. Ramaiah College of Arts, Science and Commerce
Bengaluru, Karnataka06.2005
Bachelor’s - Microbiology
Sri. Bhagwan Mahaveer Jain College
Bengaluru, Karnataka05.2003
Diploma - Genetic Engineering
Jain Institute of Vocational Studies
01.2002
Diploma - Plant Tissue Culture
Jain Institute of Vocational Studies
01.2001
Skills
- Effective communication
- Interpersonal skills
- Strong interpersonal skills in teams
- Exposure to varied therapeutic area
- Ability to understand client needs and objectives
- Clinical data management
- Oracle Clinical
- Medidata Rave
- Project management
- Staff management
Accomplishments
• CEO Defining Principal awards- 2020 PPD will to win- The CEO Defining Principles Awards is an annual program designed to recognize and reward employees who display behaviors aligned with our Defining Principles and who generate outcomes that support achievement of our company growth drivers. Received this award for working with the global team as a part of the project team which exemplified exceptional performance.
• Employee of the quarter-Oct 20- Contribution in hiring, onboarding, training CDA’s.
• Employee of the month Sep20- Received for hiring and onboarding CDA’s on much faster pace to a project.
• CEO Defining Principal awards- 2018 PPD will to win- It’s an annual global award across PPD which is provided by the CEO of the Company- received for working with the global team on multiple client deliverables and regulatory audits for a study in 2018.
• MBO Award- It’s is a prestigious global award across inVentiv Health, received for Leveraging differentiators and drive Innovation received by president of the company.
• Awarded several Extra Effort awards as appreciation for hard work & Commitment towards Quality.
• Exceptional performance award- Received consistently twice for the contribution of success in business unit.
Languages
English
Hindi
Kannada
Deutsch
Timeline
Senior CDM PM, CDM
PPD Part of Thermofisher PVT LTD
06.2023 - Current
Senior Manager, CDM
Pharmaceutical Product Development
04.2020 - 05.2023
Manager, CDM
Pharmaceutical Product Development
08.2017 - 03.2020
Manager, CDM
inVentiv International Pharma Services Private Ltd
04.2016 - 08.2017
External Lab Data Manager
Accenture Services Pvt Ltd
02.2007 - 03.2011
QC Microbiologist
Tetragon Chemie Pvt Ltd
09.2005 - 02.2007
Bachelor’s - Microbiology
Sri. Bhagwan Mahaveer Jain College
Diploma - Genetic Engineering
Jain Institute of Vocational Studies
Diploma - Plant Tissue Culture
Jain Institute of Vocational Studies
Master of Science - Microbiology
M.S. Ramaiah College of Arts, Science and Commerce