Sonal Shrivastava

As a Senior Manager, Data Management I am responsible for the oversight of a team of high-level contributors. I my current role I am providing direct oversight to group experienced Data Management Leads and directly responsible for successful project deliverables, on time with high quality. I am also responsible to resource client projects with suitably developed professionals and to retain and develop these professionals within my current organization. As a Senior Manager I am responsible to promote new business by participating in project bids and client presentations, as appropriate and provide expertise and consultation to project teams. Below are the further details about my roles and responsibilities.

Team Leadership

· Ensure team delivery of high-quality project deliverables by monitoring performance

· Train and mentor team according to job role expectations, acting as an SME for a functional process or account as applicable

· Meet with full team on a regular basis with comprehensive communication and guidance

· Conduct individual 1:1s with all staff on a regular basis

· Independently execute the full range of duties relevant to the leadership, management, and development of team members to ensure their performance meets or exceeds

· Manage and oversee departmental activities including appropriate resourcing of staff, staff assignments, quality control and timely delivery of project deliverables

· Awareness around team performance and impacts to accounts team is contributing to, collaborate with Account Lead colleagues where AL is not LM

· Promptly deliver positive and constructive feedback to team members

Account Leadership

· Point of contact for clients and within my current organization for account specific matters requiring escalation to senior management

· Proactively identify potential issues/concerns related to DM on the account that may adversely affect strategic partnership with the client and communicate those to senior management for preemptive measures

· Maintain and strengthen effective working relationship with Biostatistics/ Account Lead on mutual accounts

· Maintain seamless communication with the account staff to ensure study/project progress, timelines, quality, budget and all the deliverables are being met with quality

· Implement strategies for the maintenance and growth of the partnership to ensure that deliverables are of high-quality including representation and successful support for bid pursuit meetings

· Own and maintain partnership training curricula

· Oversee and coordinate the implementation of client processes (if applicable) and optimization of those processes (LMS Review, Training modules creation, maintain SOP list, process update communication, authoring/customizing partnership process documents, mentoring, etc.)

· Assigned as QI manager on partnership QIs

· Work with each regional head and plan for long term recruitment strategy

· Oversee/review resource requirements across the portfolio of studies/projects within a client and communicate with Sr. Management at Parexel

· Collaborate with Project Management Office and Project Quality Lead to oversee/calculate KPI/Metrics for account

· Oversee/review financial score of an account and generate summary table

· Facilitate “Lessons Learned” after project completion and determine improvement opportunities within the Account

· Have regular meetings with direct reports and staff within an account

· Attend regular account oversight client meetings (such as weekly meetings, monthly functional management team meetings, quarterly operational management team meetings, bi-yearly executive steering committee meetings, etc.)

Quality Management & Compliance

· Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of activities

· Develop team to independent data collection for KPIs, Metrics, dashboards as applicable

· Lead reviews of role specific training curricula – as applicable

· Lead Parexel process documents authoring or reviewing

· Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements and Parexel processes

· Check quality of team deliverables and proper remedial action

Financial & Resource Management

• Ensure proper resourcing of team

• Proactively plan and support financial excellence

• Drive team compliance and proper execution of financial reviews

• Provide feedback on team financials and resourcing through collaboration with Subject Matter Experts

Initiatives & Business Development

· Lead and Contribute to initiatives that requires cross functional collaborations

· Lead and Contribute to bid pursuit activities by supporting team and/or attending bid pursuit opportunities, including new partnership opportunities

· Lead and/or Participate in Parexel and department system/standards improvement activities

General Activities

· Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner

· Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)

• Led a group of Data Management Leads to ensure smooth and quality delivery of projects within timelines
• Program level Functional lead Accountability and oversight for different Enterprise and Biotech sponsor accounts
• Ensuring appropriate resourcing on the projects in coordination with DML, PL and PRO team Facilitate “Lessons Learned” after project completion and determines improvement opportunities within the Account Maintain seamless communication with the account staff to ensure study/project progress, timelines, quality, budget and all the deliverables are being met with quality Drive team compliance and proper execution of financial reviews Involvement in study audits, Qis and Bid defense as required Involved in interview process for the DMLs Representing Parexel at some of the Global forums: SCDM 2021: Academia session: Topic: “Session 2: Conduct and Close out- Research Management”; SCDM 2020: Participated as a Panelist : Topic “Abstract_ A Deep Dive into Master Protocol Trial and Data Management – Experts Opinion” Lead and/or Contribute to initiatives that requires cross functional collaborations: J Review Business owner role; CDE change Agent: Leading the DRA initiative from India; Part of global team for providing inputs to Data cleaning SOP, Leading the Intern Program.; SCDM and CCDM global SPOC.

• Manager leading a group of Data Mangers (presently around 17) to ensure successful delivery of the project deliverables, on time with high quality
• Involved in training, mentoring and allocating team members according to their ability
• Monitoring productivity and utilization for team members
• Check quality of team deliverables and appropriate remedial action
• Meeting client and business needs to have all Biotech projects optimally resourced with suitably experienced staff
• Monitor performance by close interaction with cross functional team
• Participate in PAREXEL and departmental system/standards improvement activities
• Participates in formal staff review processes e.g
• Performance and salary reviews to corporate standards and timescales
• Supporting Data management recruitment by taking interviews as required
• Complete routine administrative tasks in a timely manner (e.g
• Timesheets, metrics, travel expense claims
• Involved in SME selection process as required
• Initiatives: 1) Global SPOC from India for the conferences which includes coordinating for SCDM membership, CCDM exams, Booth set up; webinars, maintenance of financial trackers, event calendars, providing knowledge sharing platform for Parexel employees to disseminate the conference learnings
• 2) Hall Of Fame (Recognition initiative for India and South Africa): Core remember of the HOF team
• Conceptualization, Communication, Roll out and Maintenance, Providing metrics to leadership
• 3) Onboarding of New joiners: Preparation of onboarding materials, DM specific induction trainings.

• Project lead from the Data Management for end to end study deliverable
• Preparing assumptions for bidding and monitoring the study financials
• Vendor Quality checks and oversight
• Monitoring KPIs and communicating to higher management
• SWP review and maintenance
• SME for third party data
• Process training for new employees.

• Provide timely and professional ongoing management of clinical trial data Define, Implement and Monitor the Data Management Plan, the Project execution strategy, tracking progress and performance with respect to speed and quality
• Contributing effectively towards the development of eCRF standards and accompanying metadata, validations, CCGs etc.

• Data review and cleaning Quality checks implementation Coordinating with clinical team/ study team for data management deliverables

• Performing Data review and Cleaning
• Participates in designing the Project Management Plan and defines timelines and assigns job responsibilities
• Trains the personnel on the process flow and the Standard Operating Procedures, Company Policies, Documents, Registers, Templates, Forms etc
• To be maintained and followed
• Medical coding of Medical Terms, Medications and Adverse Events using MedDRA and WHO Drug Dictionary
• Serves as the primary contact with the Sponsors for the Clinical Data Management projects
• Responsible for project status reporting and data clean-up process through data archival
• Participating in recruiting, training and the development of employees.

I had a year of experience as a lecturer in Faculty of Pharmacy where I was appointed as a lecturer for B. Pharmacy students and was teaching Pharmacology. I was also responsible for taking laboratory classes for the students.