Application

Rahul from Denmark applies for Blue Card Denmark

Life science technicians (excluding medical)

Personal data:

For personal data please contact us
with the following Applicants-ID: 16681

Profession:

Name of profession: Life science technicians (excluding medical) Name of latest business sector: Clinical Data Management Latest occupation/title: Trial Manager, CDM Latest main activities: Handling multiple studies startup and closeout phase

Education:

Completed education: bachelor Title or Qualification: Bachelors in Phamacy Specialisation: Additional trainings: Lean Six Sigma-Basic

Preferred countries:

1. Preferred country | region / city: Denmark | 2. Preferred country | region / city: Germany | 3. Preferred country | region / city: Netherlands |

Language skills:

1. Language skills: english => excellent 2. Language skills: english => 3. Language skills: Hindi => excellent

Personal note /detailed application:

I am currently working for Cognizant Technology Solution India PVT Ltd. as Trial Manager (Clinical Data Management) with 8+ years of core experience in Clinical Data Management. I am based in Copenhagen, Denmark at Clients Headquarter, working on in-house and CRO outsourced projects. I have experience in handling Phase 1, 2, 3 and Observational trials with multiple therapeutic areas
(Oncology, Respiratory, Diabetes etc.)

Skills:
Project Management,Clinical Data Management,Vendor Management,Line/Team Management
,Client Management, MS Office, Windows , PowerPoint etc

Software and Tools:
Medidata RAVE,J-Review,Oracle Clinical,InForm, DataTrak, CISIV,SAS System 8,SAS viewer, Adobe Acrobat, CITRIX client interface,eTMF,WEBEX and Live meeting applications,P-CRF Indexing tool,P-CRF Database etc.


2015-10 - 2016-10 Trial Manager, Clinical Data Management
Cognizant Technology Solutions Copenhagen , Denmark
1. Work with Study groups at Headquarters for Clinical Data Management activities. Review Study Outline,
Protocol and define the complexity of trials and scope of study design during review rounds.
2. Participate in CRO selections and scrutinizing the vendors (Bid Defense Meetings) for outsourced projects.
3. Manage multiple studies as Trial Manager during the course of study and oversee all Data Management
activities.
4. Responsible for Hands-on during Study Design phase and perform all study startup activities. (As mentioned
earlier in LDM role)
5. Handle multiple CROs and ensure completion of deliverable agreed in Contracts finalized post BID Defense
meetings.
6. Perform regular Quality review cycles to check the progress of projects assigned in conduct phase.
7. Perform QC for Paper CRF / Subject Diaries designed by Peers and approve the document upon closure of
comments.
8. Ensuring Study Design and Final study data comply as per CDISC and SDTM standards.
9. Conduct (weekly-fortnightly) Meetings within study groups, Vendors, in-house programmers,coding ,safety
team etc.
10. Update Management on Progress of Projects and upcoming milestones through dashboards,
presentations , trackers etc.
11. Coordinate with Data Managers until successful DBL and Study Reports.
12. Participate in Study result meetings and share overall learning on Project within department/Project.
13. Handle invoices, billing and forecast budget for trials assigned and discuss the same with Group Head.
14. Training Sites, monitors, study group Members on EDC or more systems involved. Presenting at
Investigators Meeting.
15. Participate in Process Improvement Projects and regularly provide feedback to the study group.
16. Facilitate Face to Face Meetings within study group, external vendors at Headquarters.
2012-10 - 2015-10 Line Manager, Clinical Data Management
Cognizant Technology Solutions, Mumbai
1. Handling a team of 10-15 data managers to perform end to end Clinical Data Management activities.
2. Responsible for overall quality/Delivery of assigned studies from the Data management team from Design
to Close out of the studies.
3. Assign/Delegate/track progress of activities performed within team for multiple projects.
4. Goal setting and work expectation setting for the Team.
5. Perform annual performance appraisals of direct reportees and provide regular feedback through 1 to 1 and team Meetings.
6. People management, Conflict Management and resource/work utilization across projects.
7. Conduct necessary training, mentoring, presentations etc. sessions required to up-skill team members for work assigned.
8. Active member of Process Improvement Team and ensure team is aware of process updates and latest changes within Organization.
Work with sponsor for implementation of the new fast tracked set-up process by handling the pilot studies and providing feedback on the same.
9. Review, write and present SOPs/ Bulletins/ Templates etc. within Project as per requirements.
10. Managing and approving leaves for Data Management Team. Resignations/Abscond communication to Group Lead/Operation Manager.
11. Main point of contact for study audits/ Inspections for assigned Projects. Also ensure compliance and audit/inspection readiness within team.
12. To collaborate with different functional group within/outside Organization like Clinical, bio-statistics and statistical programming, Study design developers, Medical coding team, Safety team, Marketing team, Process Improvement group, Outsourcing team, Vendors for LAB, IVRS etc.
13. Applying study metrics within team to track progress/ heath of assigned projects, identify new resourcing requirements, potential risks with mitigation plans, upcoming milestones, achievements etc. Discuss the success and failure within team and regulate learning and best practices for team/project etc.
14. Provide guidance for solving different issues as a SME for Clinical Data Management.
15. Encourage healthy bond within team, celebrate achievements, develop an innovation culture which helps process and project improvement.
16. Participation in recruiting strategies and staffing needs based on the work load.
As a Team Leader , successfully delivered multiple Phase 1, 2 and 3 studies with different therapeutic areas.Have worked on business critical projects and delivered it on fast track development and submissions.

2010-09 - 2012-10 Lead Clinical Data Manager
Cognizant Technology Solutions, Mumbai,

Handled mix of 7 to 8 International studies in parallel starting in Study Design and/or Conduct Phase with support
Data Managers in Study Conduct Phase.
Study Start-up Phase:
1. Working with Study group during Trial Outline/Protocol Draft by performing review to input valuable
comments in anticipation for Data Management requirements in Design, Conduct, Closeout phases.
2. Initiation of Study Kick-Off Meetings and Study Creation within Organization repositories as preparation for Study Startup Phase.
3. Review of Draft Protocol/Finalized if available for defining the complexity of the trial for outlining the study Project Plan and timelines for Study Design.
4. Proactive research to highlight CRFs/ Edit Checks / integrations required out of the standard CRFs and any new requirements observed on protocol to initiate request for trial specific CRF/ Edit Checks /Integrations etc.
5. Coordinating with Project Manager for Trial Forecast based on experience/study design/project libraries for budgeting of the Trial.
6. Creation of CRF Specification based on the Protocol, Study requirements, Project Standards for Therapeutic Area etc.
7. Creation of Edit Checks Specification based on the Protocol, Study requirements, Project Standards for Therapeutic Area etc.
8. Creation, distribution, coordination, compilation and closure of Review comments document for Study Groups and teams involved throughout the course of Study Design Phase.
9. Creation of Requirements Specifications for study programming team to map IVRS, Reports, Clinical systems, Data Extraction etc.
10. Perform User Acceptance Testing (UAT) for CRF, Edit Checks, Integrations, Mapping, data Extractions,Roles and Restrictions, Test Data for External Loads etc.
11. Creation of Data Management Plan to define the flow, quality parameters, timelines, study members list etc.for the Trial with processes applicable/references required like links/documents/SOPs etc. during the study period. Updating this Live document in timely manner based on the changes/agreements/ requirements in future.
12. During the entire Design Phase ensuring 100% compliance to documentation and ensuring timely
update/placement of documents in Repositories per TMF filing requirements.
13. Undertaking all specified SOP training, Upgrading systems training to ensure compliance and Process adherence during Study Startup, Conduct and Closeout phases.
14. Presenting/Training during the Investigators/Monitors Meeting before the EDC Go Live.
15. Ensuring successful Go Live! And deployment of Production Database before FPFV of the study.
16. Arranging Meetings within study group for screen review, issue discussion, planning, tracking and documenting Minutes of Meeting. Circulating and following up on the action items agreed in the meeting until closure.

Study Conduct Phase:
1. Performing day to day Clinical Data Review, Query Management, SAS data listing review, extraction of reports etc.
2. Reviewing Study Protocol, Data Management documents, Creating Trackers and Study Metric reports for client and internal tracking.
3. Performing Third Party Data reconciliation for External Lab, IVRS data etc.
4. Performing SAE reconciliation between Safety Database and Clinical Database.
5. Ensuring No backlogs for data review, missing Data, Queries, Technical Issues, SDV, freezing and Locking data.
6. Resolve all findings/Issues/queries/Technical complaints/Clarifications by stipulated deadlines.
7. Flag any inconsistency on Data collections, study design, incorrect queries, technical issues, compliance issues etc.
8. Study Level Agreements/Decisions/study specific issues to be updated on study trackers for retrieval/audits/reference during the study period.
9. Coordinating with other teams like Coding/IVRS/Safety department/Programming and BioStats for
completeness and Overall status of the activities performed.
10. Ensuring all study SLAs and KPIs are met including the timelines for Ongoing Data Validation activities.
11. Coordinate /execute changes (Change Request/Migration of database) on the Clinical Systems per Study
Protocol Amendments/study decision to change design/corrections of checks/CRF entries during Conduct phase
of the study.
12.Updating/Creating documents during study conduct phase and ensuring timely placement of the same in study repositories for TMF archiving.
13. Knowledge transfer, Mentoring, Archival and Storage/Retrieval of Documents/mails/ Minutes of Meeting for future references and smooth handover if any transitions during the course of the study.
Study Closeout Phase:
1. Ensure all study timelines are met with High quality as defined for the study and all stake holders are informed for the same.
2. Creation of Study Close-Out Plan (LPLV to DBL) and discussion with Study group on study progress.
3. Proactive follow-ups with all stake holders for pending activities during the Closeout Phase.
4. Tracking Missing Data and following up with sites/Monitors until completion.
5. Ensuring all queries are closed, SDV completed, External data received/validated and subjects are declared clean on ongoing basis.
6. Freezing and Hard locking data of completion of validation activities before Database Lock.
7. Ensuring closure of all open documents, comments in issue logs, Clean patient tracker, decision logs,revoking access and stopping extraction of data, reports.
8. Hosting clean file meeting for study group and documenting clean file form with agreement from study group.
9. Discussion on issues, PD listing, critical SAEs, study deviations, missing data, critical variables etc. during Clean file Meeting and document the decisions in Clean-file minutes of meeting.
10. Completing STMF as per process within expected days and also ensuring observations are documented per findings.
11. Filing deviations for Non-compliance observed, adding narratives for study group for inconsistencies,agreements, deviation etc.
12. Coordinating with Study Stats and Programming for Data Required during Execution of Statistical
Analysis Plan.
13. Maintaining confidentiality and following Organizational instruction as per the requirements until studyreport/results.

2008-10 - 2009-10 Clinical Data Manager
Cognizant Technology Solutions, Mumbai,

1. Data review and Discrepancy management for assign studies.
2. Query Management for assigned projects by the Team Leader.
3. Study Status tracking and collaborating with support teams like coding, programming, etc.
4. Perform ongoing Data Cleaning cycles for consistency and High Quality of data throughout the Conduct Phase.
5. Issue follow-up with all applicable stake holders and tracking until resolution.
6. Handling Technical issues in collaboration with tech/Support teams.
7. Performing Manual/SAS checks and documenting comments with actions applicable in Database etc.
8. Providing Clean Patient Tracker, Study Metrics reports, Billing, Missing Pages Report, etc
9. Resolution of Site, Monitor and Study Team queries.
10. Handling multiple studies (3 to 4) in parallel.
11. Creating PPTs for lessons Learnt and presenting it in team meetings.
12. Performing SAE/TPD reconciliation for multiple studies.
13. Freezing and Hard locking subjects data before DBL.
14. Archive all study related documents regularly in study repositories.
15. Undergoing training, reading Sops, taking assessments to enhance additional skill-set time to time.

Certification and Awards:

2008-02 Participation Current Developments in Pharmaceutical Technology and Practice
2008-12 Special Contribution Award
2009-02 Wow Award for Outstanding performance
2009-04 Basic German Language Training
2009-12 Opel Award for Outstanding performance
2010-05 Wow Award for Outstanding performance
2011-01 Medidata RAVE Application Trainer
2011-08 FOCUS: Leadership Development Certification Program for SME
2012-03 Opel Award for Outstanding performance
2012-06 Wow Award for Outstanding performance
2012-08 Opel Award for Outstanding performance
2012-11 Opel Award for Outstanding performance
2012-12 Opel Award for Outstanding performance
2013-10 Certified Idea Champion for conducting Managed Innovation
2013-11 STAR Certification Program for Frontline Supervisors
2014-10 Data Management STAR Award
2014-12 STAR of the month
2015-01 STAR team of the month
2015-03 Frontline Leadership Award
2015-05 Participation in DMQL workshop
2015-06 Lean with Basic Six Sigma
2015-09 EMBARK: Leadership Development Program for Team Leads
 

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