Sheeraz Raja Email & Phone Number

New Delhi Area, India

Sr Clinical Project Manager | ClinOps lead Asia RegionAs a highly organized and detail-oriented Clinical Project Manager, I oversee and coordinate multiple clinical trials across the Asia region, ensuring smooth operations and adherence to stringent regulatory and procedural standards. My role encompasses the management of all trial phases, from initial planning through to documentation and completion.Key Responsibilities:Clinical Trial Management: Directly manage and supervise the clinical trial team, including Clinical Project Managers and Senior Clinical Research Associates (CRAs), ensuring efficient trial execution and compliance with DNDi Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and ICH Guidelines.Budget Oversight: Accountable for the trial budget, working closely with the Head of Disease/Project Leaders to maintain financial responsibility and ensure cost-effectiveness throughout the study lifecycle.Regulatory Compliance: Ensure adherence to local, regional, and international regulatory requirements, facilitating smooth regulatory submissions and audits.Digital Innovation: Drive digital transformation within the organization by leading the implementation of Clinical Trial Management Systems (CTMS) like Veeva, Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM) systems, and other digital tools to enhance process efficiency and data accuracy.In this role, I am committed to advancing clinical research through meticulous management and innovative solutions, contributing to the successful development of groundbreaking treatments and therapies.

Mumbai Area, India

• Build and develop the clinical development department.• Oversee the activities of PM, MM, Sr. CRA, CRA, CRA-1, Medical Monitor, CTMM, CTA, Pharmacist and others in the department.• Responsible for management and development of project team.• Oversee professional development of all clinical development staff.• Assess and address training requirements of clinical development department.• Ensure that the staff with assigned specific responsibilities are trained and qualified in carrying out the activity assigned to them.• Oversee and support the development of SOPs that meet regulatory requirements and is responsible for their implementations.• Train others in the appropriate application of clinical research, laws, regulations, guidelines as well as compliance with applicable SOPs.• Liaise between the sponsor and investigators at investigators sites.• Supervise project management of Clinical Development department.• Conduct project team meetings.• Support the development of study documents such as protocols, subject information sheet/ Informed consent form, Case report forms etc.• Review protocol prior to submission for regulatory approval.• Review other study related documents prior to their finalization.• Ensure that the project management plan in place, prior to the start of the trial.• Finalize the final list of sites selected for the study.• Manage and attend the Investigator’s meeting• Ensure that the participating sites are provided regular updates on the trial in the form of periodic newsletters/updates.• Advise sites, PM, Sr. CRA, CTMM on the management of issues at sites.• Participate in the internal /external study related audits.• Ensure timely implementation of contingency measures to meet timelines.• Carry out the responsibilities in the absence of the Head clinical development.

Hyderabad Area, India

Has operational end to end responsibility for assigned supply activity. Leads and manages all project and local network activities and participates in cross-functional teams.• Coordinates internal and external stakeholders, customers and/or vendors.• Contribute as unit representative on project teams. Ensure that own deliverables are met. • Act as unit representative on development teams and/or other cross functional teams.• Communicates issues to involved stakeholders and propose corrective actions.• Ensures lessons learned sessions are in place for own tasks.• Coaching and technical training as recognized technical expert or leader. Act as mentor for junior and senior associates (including academics).• Understand resource constraints and identify and lead cost saving opportunities.• Interpret results, evaluate data, draw conclusions and report back to team and management.• Support cultural evolution within own function by showing positive work ethics and influencing others.• As process owner being accountable for process improvement. Drive implementation and sustain phase within area of expertise.• Assesses risks in the general set-up of the particular distribution strategy for a clinical trial.• Sets the IRT specifications. Perform URS & UAT. Manage IRT vendors. • Reviews and updates IRT supply parameters dynamically over study lifetime to reduce overage and achieve financial targets. • Reviews actual enrollment data and updates the demand forecast and distribution plan based on actual recruitment/demand for ongoing studies. • Assumes the responsibility as DSM representative at CTT meetings.• Owns and monitors Health Indicators for the distribution chain of the assigned projects.• Manages shelf life planning on CFG level and extensions of shelf-life in the entire distribution chain.• Is responsible for distribution budget; issues purchase orders. • Manages studies independently.• Supports internal/external inspections and audits.

New Delhi Area, India

New Delhi Area, India

New Delhi Area, India