Sheetal Dyall-Samani

Trial Delivery Manager assigned to Johnson and Johnson Innovative Medicine.

• Currently assigned to MonumenTAL-6 (GEM study).
• Responsible for the global coordination of trial delivery management activities for internally managed trials.
• Oversight of site activation and enrolment, ensuring alignment with study milestones. Achieved First Site Open, First Subject Screened and First Subject Enrolled on my current study.
• Point of contact for local country teams to address trial-related issues.
• Single point of contact for vendor management and day-to-day vendor oversight activities, including budget oversight.
• Development of study documents (ICF, Monitoring Plans, SIPPM, Newsletters) and training material.
• Lead Study Management Team Meetings, and contribute to Cross-Functional Trial Team Meetings.
• Proactively monitor, resolve, and / or escalate operational risks that impact trial budget, quality, and timeline delivery.
• Oversight of Protocol Deviations and Issue Escalations.
• Collaboration with the Data Science team to implement the ORBIT Tool for automation of key study trackers to increase efficiency and minimize manual updates.

Provided Clinical Trial Management Services to Bristol Myers-Squibb.

Clinical Functional Lead, accountable for the oversight and coordination of trial activities. Ensure the delivery of trial activities according to protocol, ICH/GCP and or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance. Therapeutic area primarily oncology, however, some experience in Innovative Medicine-hepatology and immunology.

Responsibilities:

• Countries handled: Belgium, Netherlands, Ireland and UK (multiple studies and multiple sites)
• Study stages handled: Feasibility, Set Up, Recruitment, Maintenance and Close Out
• Development of Country Informed Consent Forms and other study documents
• Oversight of Initial Submissions and amendments to Health Authorities and Ethics Committees.
• Led Study Management Team Meetings.
• Closely monitor enrolment activities, and implementing strategies to improve enrolment at country and site level.
• Oversight of country and site budgets, and site budget escalations.
• Attending EC Meetings to facilitate response to queries.

Provided Clinical Study Manager Services to Novartis.

• Accountable for day to day planning, executing, reporting and budget (from site feasibility up to and including study site close out) of assigned Innovative Medicines Phase II - IV Global Drug Development and Local studies (interventional and non-interventional) in Neuroscience in compliance with Novartis processes and ICH-GCP and regulatory requirements.
• Countries handled: Ireland and UK (multiple studies and multiple sites) across 10 studies
• Study stages handled: Feasibility, Set Up, Recruitment, Maintenance and Close Out
• Phases 2 to 4 including Non-Interventional Trials in Multiple Sclerosis
• Oversight of site budget ad payment
• Submissions to Ethics Committees, and collaborating with the Regulatory team to support MHRA submissions.
• Oversight of field-based Monitors, supporting co-monitoring visits.
• Responsible for site budgets and payments.
• Subject Matter Expert for Novartis Patient Engagement Initiatives.

Provided Site Activation Services to Eli Lilly.

• European Site Activation Associate responsible for site activation and study management of the country sites in alignment with company Standard Operating Procedures and ICH-GCP and regulatory requirements.
• Countries handled: UK and Ireland
• Study stages handled: Feasibility, Set Up, Recruitment, Maintenance and Close Out
• Phase 3 breast cancer study, and a Phase 1/2 adaptive design pancreatic cancer study, and 4 maintenance oncology studies (Phases 1-3).
• Prepare and manage Ethics and regulatory submissions in countries of responsibilities via European regulatory processes to support clinical research.
• Negotiation of site budgets and clinical trial agreements
• Write initial country/site study-level ICFs, as well as revisions due to protocol amendments, risk profile updates, etc. Contribute to the country specific ICF template review.
• Site relationship manager- develop and maintain relationships with study sites to facilitate ongoing trials, and ensure any further trials placed with such sites are set up smoothly.
• Subject Matter Expert for Contract and Budget for the UK Lilly Affiliate.

Study-level country coordinator assigned to PAREXEL strategic partnership studies- Pfizer Inc., Regeneron Inc., as well as less established biotechnology start-ups with limited clinical research experience in the EU.

• Study start-up activities in the UK and Ireland - site identification, feasibility, collection of essential documents, country ICF customization, EC and RA submissions through to R&D approval, negotiate Clinical Trial Agreements, IP release to sites.
• NIHR submissions for early feedback, site identification and site intelligence to get studies added to the NIHR portfolio.
• Set up of studies from Phases 1-3, including First-In-Patient studies

Executed start-up activities and ethics submissions for studies across all therapeutic areas from site selection leading up to drug release to site in accordance with ICH-GCP and country-specific regulations.

• Handled site selection through to drug release, adhering to ICH-GCP guidelines.
• Managed compliance with country-specific regulations in UK and Europe, including Germany and Italy.
• Oversaw feasibility and set-up stages for Phase 3 dermatology studies.
• Coordinated amendments during recruitment and maintenance phases to ensure timely CSR submission.