Iqbal Ahmed

• Around 17 years of Clinical Research Experience in core Clinical Data Management; majorly working in Lead roles for Data management projects for all clinical study phases from Phase 1 to Phase 4, including RWLP studies .
• In Study Startup, Conduct and Closeout activities - Independently managing end to end deliverables of projects, understanding of relevant stake holders or customer requirements and ensuring high quality deliverables.
• Professional experience includes different roles on efficient Project Management, People Management , Functional Lead - in Planning, key communications, Audit facing , BDM representative from DM function , Co-Supporting CSR Review .
• Extensively worked on Customer relationship management through CRO work experience and Functional lead perspective from Sponsor side role;
• Adhering to escalation matrix management, proactive risk identification and mitigation. Ensures early and routine cross-functional interrogation of clinical data in order to modify/correct site behaviors or other aspects of study conduct in a way that eliminates or neutralizes risks to a study’s data integrity.
• Identify and reconcile errors in clinical data used by statistical programmers and statisticians to ensure accurate results.
• Therapeutic area experience in Oncology- Biologics/Biosimilars , Cardiovascular, Rheumatology, Dermatology, Gastroenterology and Pediatric studies - across various phases of trials.
• Overall knowledge of drug development process, Clinical research, Good Clinical Practice, ICH, GCDMP and Regulatory activities.
• Define quality strategy in DMQP (Data Management Quality Plan) for entire project with inputs from clinical team Review trial design, flow chart, clinical assessment and statistical analysis section of the protocol.
• Author Data management section and provide inputs to clinical trial report end of text. Co-author various Data Management SOP's, Business Guidance and procedural documents Develop and validate clinical and electronic data capture systems using requirements such as scope, processes, alternatives, and risks.
• Build and design CDISC complaint eCRF(s), trial validation plan and working experience on SDTM (Study Data Tabulation Model) datasets that are to be submitted as part of a product application to a regulatory authority.
• Ensures early and routine cross-functional interrogation of clinical data in order to modify/correct site behaviors or other aspects of study conduct in a way that eliminates or neutralizes risks to a study’s data integrity.
• Bridge between clinical stakeholders and data management colleagues involved in clinical trials. Integrates and aligns study data review process across functions
• Define quality strategy with CRO partners in DMQP (Data Management Quality Plan) for entire project with inputs from clinical team and other stake holders.

• Evaluate and contribute in Vendor selection process for Data Management services for Biologics Projects
• Provides leadership, directions and oversight of CRO and vendors in execution of protocol for Data Management deliverables
• Review of RFP proposals and overall review of budget and key units’ evaluation for DM function as received for any BD meetings
• Part of core Clinical Project team along with key stake holders for Strategy development, Tool selection and study results discussion for overall project
• Oversight end to end project management of Data Management deliverables including startup, conduct and closure phase of the trial for Phase 1 to 4 Clinical trials, Registry studies and Real World Study projects
• Provide key specific inputs and review on Data Management Plan finalization, Data Transfer Agreements, Safety reconciliation Plan, Milestone deliverable plans, Pharmacy manual with Ops team, Lab manual plan supporting Bio Analytical team, Edit Checks document and UAT, Support RTSM/IWRS setup with Vendor along with inputs from Stats and Ops team, and other Data Management functional documents approvals from sponsor perspective with respective CROs.

References Faiyaz Hussein – ePID Operations Manager – Novo Nordisk fzhu@novonordisk.com +45 91438491 Shakeer Saheb – Asset Lead - Pfizer shakeer.saheb@pfizer.com +91 9686171111