Sohel Hayat Khan
GLOBAL CLINICAL PROJECT LEAD
Hyderabad
Summary
Enthusiastic Project Leader experienced in developing and maintaining mutually beneficial internal and external relationships. Achieved project goals and deadlines through effective team coaching and motivation, while thriving in high-pressure environments. Focused on enhancing operations through self-motivation, diligence, and strong interpersonal and organizational skills.
Overview
9
9
years of professional experience
3
3
Languages
Work History
Global Clinical Project Lead – Rare Disease Registries
Sanofi
08.2025 - Current
- Led end-to-end management of multinational rare disease registries, ensuring compliance with sponsor SOPs, regulatory requirements, and ICH-GCP guidelines.
- Managed country feasibility assessments, site identification, and site selection activities in collaboration with Global Registry Teams and Medical Affairs.
- Coordinated study start-up activities including ethics/regulatory submissions, site activation, investigator documentation, and distribution of study materials (Protocols, CRFs, PAFs, Investigator Files).
- Oversaw site contracting and budget negotiations, ensuring timely execution of financial agreements and milestone-based site payments.
- Maintained operational oversight of registry studies across assigned countries and provided regular status updates to global stakeholders.
- Directed and coordinated Clinical Research Associates (CRAs) to ensure effective monitoring, site management, and study execution.
- Reviewed and approved Site Selection, Site Initiation, Routine Monitoring, and Close-Out Visit reports and follow-up correspondence.
- Managed registry timelines, study trackers, KPIs, risk logs, and project reporting systems to ensure study milestones were achieved.
- Collaborated with Data Management teams to monitor data quality, resolve data discrepancies, and support data integrity initiatives.
- Coordinated international data collection activities and cross-regional alignment with global Clinical Project Leads.
- Served as primary liaison between Medical Affairs, investigators, vendors, CROs, Finance, and Registry Operations teams.
- Managed vendor oversight activities including start-up support, monitoring services, and operational deliverables.
- Ensured robust pharmacovigilance and safety reporting processes in accordance with local regulations and sponsor requirements.
- Maintained audit and inspection readiness through proactive quality oversight, deviation management, root cause analysis, and CAPA implementation.
- Led training initiatives for new CRAs and temporary resources, supporting onboarding and continuous development programs.
- Maintained study documentation, trackers, databases, and electronic Trial Master Files (eTMF) throughout the study lifecycle.
- Contributed to Quality Management System (QMS) improvements, SOP development, process optimization, and CAPA effectiveness reviews.
- Participated in investigator meetings, study governance meetings, audits, inspections, and global operational forums.
- Developed and executed strategic project plans, ensuring alignment of timelines, resources, budgets, and stakeholder expectations.
- Fostered strong relationships with internal and external stakeholders, driving collaboration, issue resolution, and continuous process improvement.
- Monitored study performance metrics and implemented corrective actions to mitigate operational risks and enhance project delivery.
- Led global rare disease registry projects, ensuring compliance with regulatory requirements and enhancing data quality.
- Developed strategic plans for registry initiatives, driving stakeholder engagement and improving patient enrollment rates.
- Collaborated with cross-functional teams to streamline project workflows, resulting in increased operational efficiency.
- Mentored junior project staff, fostering their professional development and enhancing team performance.
ASSOCIATE CENTRALISED MONITORING LEAD (ACML, Home Based)
IQVIA
02.2021 - 08.2025
- Provide support to CMS leads on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operation 'Plan (COP) from Applications/ Analytics/ Therapeutics/ Quality perspective.
- May perform functional lead responsibilities for assigned project deliverables for certain smaller or less complex projects from start-up to final deliverables including closeout.
- Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested and note CMS specific action items.
- Support CMS Lead to oversee the Finance related information in the study and provide inputs to EAC.
- May manage Investigator Payment Activity from set up to close out of the study.
- Contribute to the development and use of study management plans including Risk Assessment and Mitigation Plan, specific tools and document templates and/or other study specific plans to evaluate the quality and integrity of the study, including complete and accurate documentation so that the project is audit ready.
- Support CMS Lead/project team to develop monitoring strategy including monitoring triggers/thresholds, and the study specific analytics strategy, work on developing analytics based on applicable study specific plans, develop new analytics proposal as per customers demand, perform quality reviews on the analytical output created by the team members.
- Manage operational insight of the assigned project(s) and perform the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and discuss the action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).
- Provide Inputs to CMS Lead/Project team, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.
- Identify the value adds from the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders.
- Support in managing project resources (CRAs/CTAs/Centralized monitoring team).
- Support in performing the IP management for the assigned study to identify risk and propose mitigation plan, if any (including re-supply, re-labelling, Import/export licenses etc.).
- Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and enable early identification of site-level risk/issue(s) and take appropriate action.
- Monitor operational triggers/Key Data Points/data trends and monitor their compliance check by performing regular Quality Check.
- Evaluate the quality and integrity of site practices related to the proper conduct of the study as per protocol.
- Create and maintain relevant project documents/ trackers.
- Ensure accurate completion and maintenance of internal systems, tracking tools and timelines.
- Coordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles.
- Act as lead for the reviewers performing Subject Level Data Review, create plans to review the clinical data of subjects in accordance with project requirements, maintain study metrics on delivery and quality.
- Perform regular quality checks for the data reviewed at subject-level.
- Participate in (study) team meetings/Project kick off meetings and interaction with cross functional staff to verify information and/or triage new data issues.
- Review site visit reports per annotations, SOPs, guidelines etc., identify issues and escalate the same to the Clinical Lead, assist with creating annotations, CRA trainings, support to conduct monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.
- May require to mentor or coach for junior CMS staff and foster ownership and collaboration with the team.
PROJECT MANAGEMENT ANALYST (PMA)
IQVIA
08.2019 - 02.2021
- Establishes and maintains a project monitoring, control and reporting system that supports on-going assessment of project performance and facilitates informed and timely adjustment of project execution to achieve project objectives.
- Develops and maintains the Project Execution Plan sections related to project tracking, trending, reporting and change control elements.
- Applies strong time management, planning, organizational, decision making and problem-solving skills to resolve issues in an effective and timely manner.
- Travels as needed to support project objectives.
- Utilizes strong proficiency in office applications such as Microsoft Office and common project controls applications to analyze and communicate project related metrics.
- Executes the roles and responsibilities of the position in a legal, ethical, and professional manner and compliant with Company Policies and Procedures.
- Develops, or leads development of, the project schedule and cost estimates and subsequent establishment of the schedule and cost baselines.
- Establishes and maintains baseline change control, using change control logs and project change notices. Assists the Clinical Project Manager in the processing of change order requests, including change order cost estimation and impact.
- Maintains an up-to-date commitment & contract log in support of contract payment.
- Develops / validates the project estimate.
- Establishes budgets based on the approved project estimate.
- Manages cost commitments.
- Reviews and approves vendor invoices.
- Assesses and submits project accruals to accounting personnel.
- Implements and manages the change control process.
- Implements and manages the Risk Management Process.
- Develops and maintains project trends and forecasts.
- Integrates project schedule(s) and performs critical path and variance analysis.
- Interfaces with accounting and budgeting support personnel to help establish and manage the project cash flow.
- Assures effective reporting in the following areas (based on information provided by sponsor and Quintiles personnel): a. Cost, schedule, and scope
- Resource utilization and performance (productivity factors)
- Change orders
- Quality control, audits, and inspections
- Risk exposure and contingency reserve balance
- Open action items and lessons learned
- Runs the scheduling and execution portion of the Monthly Project Execution Meeting.
- Facilitates identification and assessment of project risks.
- Maintains the project risk register.
- Assesses contingency adequacy.
- Facilitates, as appropriate, project root cause assessments and lessons learned sessions.
- Addresses schedule and cost risks.
- Transmits project controls documentation.
- Provides final contract payout (including retention).
- Assists in closing project charge codes.
- Works with Contract Administrator to ensure all Contract Documentation has been received and properly addressed.
CLINICAL PROJECT ASSISTANT
PPD
07.2017 - 06.2019
- Review regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and client company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client.
- Liaise with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner.
- Post and distribute CTMS project specific guidance document to project team (if applicable).
- Add project team members, global, country and any project level activity plans to project in CTMS.
- Oversee the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other PPD departments.
- Coordination of eTMF/Project file set up.
- Upon direction of CTM/PM, finalize the table of content for all study files (Central, Internal, Country, Investigator), develop and distribute filing guidelines to clinical team.
- Perform file reviews and log outstanding issues in project related tracking tools.
- Submission of documents to Central and Internal files and update in CTMS.
- Develop and maintain assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines.
- Assist PM/CTM with the creation of study documents, checklists, and reports as needed.
- Assist in the creation of study specific documents and plans (e.g. Communication Plan, Project Plan, Monitoring Plan, etc.), study logs (e.g. Drug Accountability Log, Site Visit Log, etc.), study trackers (e.g. training tracker, FAQ, etc.).
- Distribute the study Q&A / Directives log to project team and/or notify project team of where updated version can be located.
- Create and maintain a Task List for the study and continue to manage progress of the clinical administration deliverables.
CLINICAL RESEARCH COORDINATOR (CRC)
JSS MEDICAL RESEARCH
03.2017 - 06.2017
- Clinical Research Coordinator:
- Patients screening and recruitment.
- Scheduling patients’ visits and study procedure as per protocol.
- Managing the day-to-day activities of a study.
- Scheduled patients' visits and study procedures per protocol.
- Patient screening and recruitment.
- Coordinated day-to-day activities of study to ensure compliance with protocols.
- Completed and ensured quality of case report forms for accurate data collection.
- Dispensed medications to study participants, ensuring adherence to protocols.
- Drug dispensing and accountability.
- Ensuring proper documentation in the Source Documents.
- Monitored status of all study activities to maintain adherence to timelines.
- Maintaining study files.
- Serving as the primary contact with subjects (on behalf of site)/sponsor/CRO/Lab/Vendor/EC.
- Preparation, Attendance and FU of SMV, and Audits.
- Conducting Feasibility studies.
- Preparation, Attendance and FU of close out visits.
Education
MSc. - Clinical Drug Development
Barts & The London School of medicine and Dentistry, Queen Mary University of London
London, United Kingdom12-2016
BSc. - Zoology, Botany & Chemistry
Pt. Ravi Shankar Shukla University
Raipur, Chhattisgarh, India08-2006
Skills
- Registry management expertise
- Leadership in clinical projects
- Rare Disease Registries
- Site initiation
- Site feasibility
- Supplier management
- Contract management
- ICH-GCP Compliance
- Ethics submissions
- Risk mitigation
Trial oversight
Regulatory adherence
Site assessment
Study initiation
Financial negotiation
Vendor management
Project supervision
Safety reporting
Stakeholder communication
Risk assessment
Cross-functional collaboration
Centralized monitoring
Operational strategy
Issue resolution
Document management
Collaborative mindset
Leadership skills
Project coordination
Project management
Process improvement
Client engagement
Timeline planning
Risk evaluation
Project execution
Organization skills
Risk analysis
Mentoring
Resource allocation
Stakeholder management
Work breakdown
Milestone management
Attention to detail
Team management
Team collaboration
Documentation management
Detail-oriented
Quality assurance
Performance evaluation
Timeline visualization
Clinical documentation management
Team motivation
Risk management
Affiliations
- Institute of Clinical Research, London, United Kingdom
- William Harvey Clinical Research Centre (CRC)- Queen Mary University of London, London, UK
Timeline
Global Clinical Project Lead – Rare Disease Registries
Sanofi
08.2025 - Current
ASSOCIATE CENTRALISED MONITORING LEAD (ACML, Home Based)
IQVIA
02.2021 - 08.2025
PROJECT MANAGEMENT ANALYST (PMA)
IQVIA
08.2019 - 02.2021
CLINICAL PROJECT ASSISTANT
PPD
07.2017 - 06.2019
CLINICAL RESEARCH COORDINATOR (CRC)
JSS MEDICAL RESEARCH
03.2017 - 06.2017
BSc. - Zoology, Botany & Chemistry
Pt. Ravi Shankar Shukla University
MSc. - Clinical Drug Development
Barts & The London School of medicine and Dentistry, Queen Mary University of London
Therapeutic Experience
- Therapeutic Area: Infectious Disease, Years Exp: 1.5, Experience (Roles): HIV Infection - 1.0 - All Clinical Research Coordinator Tasks, RSV - 0.5 - All CML Roles and Responsibilities, Varicella-Zoster Infection - 0.5 - unblinded CML Roles and responsibilities
- Therapeutic Area: Hepatology, Years Exp: 1.0, Experience (Roles): Hepatocarcinoma - 1.0 - All PMA Roles and Responsibilities
- Therapeutic Area: Neurology, Years Exp: 1.0, Experience (Roles): Degenerative disease of CNS - 1.0 - All CML Tasks
- Therapeutic Area: Rheumatology, Years Exp: 1.0, Experience (Roles): Rheumatoid Arthritis - 1.0 - All PMA Roles and Responsibilities
- Therapeutic Area: Dermatology, Years Exp: 0.5, Experience (Roles): Skin Infection - 0.5 - All RBM / CML
- Therapeutic Area: Endocrinology, Years Exp: 0.5, Experience (Roles): Diabetes Mellitus Type 2 - 0.5 - Recruited 300 patients for phase 4 trials and carried out all clinical research coordinator duties
- Therapeutic Area: Gastrointestinal, Years Exp: 0.5, Experience (Roles): Ulcerative Colitis - 0.5 - All CML Roles and Responsibilities
- Therapeutic Area: Oncology, Years Exp: 0.5, Experience (Roles): Malignant Melanoma - 0.5 - All CML Roles and responsibilities, Solid Tumor Configuration - 0.5 - All RBM / CML
- Therapeutic Area: Ophthalmology, Years Exp: 0.5, Experience (Roles): Retinal vascular occlusion - 0.5 - All PMA Roles and Responsibilities
- Therapeutic Area: Respiratory, Years Exp: 0.5, Experience (Roles): Tuberculosis - 1.0 - All PMA Roles and responsibilities
- Therapeutic Area: Genetic Disorder, Years Exp: 1, Experience (Roles): Lysosomal Storage Disorder - All responsibilities as CPL
- Therapeutic Area: COVID-19, Years Exp: 0.5, Experience (Roles): All PMA Roles and Responsibilities
- Therapeutic Area: Malignant Tumor of Brest, Years Exp: 1.0, Experience (Roles): All CML Roles and responsibilities