Linda Kelly MSc Pharm. Med.

Leader accountable for study lifecycle delivery across assigned studies, including feasibility, site identification, start-up, recruitment, quality, data delivery, and inspection-ready documentation.

• Lead country-level study delivery through oversight of local study teams and CROs, chairing country calls, aligning stakeholders, and driving timely execution of actions.
• Partner with Medical Affairs and investigator sites to support feasibility, engagement, and recruitment across assigned studies.
• Oversee EC submissions, in-country ICF issue resolution, and clinical monitoring documentation , ensuring compliant and efficient study conduct.
• Drive country inspection readiness , including preparation for and interactions with PMDA and MHRA .
• Maintain strong site relationships and support identification of potential investigator sites to enable study delivery and performance.
• Develop tracking and oversight tools and lead proactive risk and quality management to protect timelines, quality, and compliance.

• Led the cross-functional team responsible for global study delivery and served as the primary operational point of contact for leadership.
• Provided operational leadership across protocol development, study documentation, systems, outsourcing strategy, and study execution.
• Led feasibility, risk assessment, and mitigation planning to support robust study design and delivery.
• Directed investigator meeting planning and execution , supporting study launch and engagement.
• Managed timelines, budgets, and study conduct in accordance with ICH/GCP and company standards.
• Drove process improvement and innovative approaches to strengthen clinical trial execution

Global Programme Lead – Hepatitis B (HBV) Phase I/II Vaccine Clinical Trials

• Led strategic cross-functional delivery of development programmes in line with ICH GCP , internal SOPs, and global regulatory requirements.
• Directed programme planning and governance , including Clinical Development Plans, Target Product Profiles, timelines, budgets, risks, and key decisions .
• Provided leadership across protocol development, study documentation, and study systems .
• Oversaw CROs, vendors, and contract resources to ensure quality, compliance, and timely delivery.

Consultant / Senior Clinical Manager – Phase I/II Gene Therapy Study in Parkinson's Disease

• Led end-to-end delivery of a complex gene therapy study , ensuring compliance with ICH GCP , ATMP guidelines , internal SOPs, and regulatory requirements.
• Provided senior study leadership across cross-functional teams, sites, and external partners to drive quality, timeline, budget, and operational performance.
• Directed study governance , including documentation, risk management, ethics and regulatory submissions, contracts, supplies, and TMF inspection readiness .

Managed CRO, vendor, site, and KOL relationships , while contributing to wider process improvement initiatives

Senior Clinical Trials Manager – Neurodegenerative Trials, Phase II/III

• Led a trial management function responsible for a portfolio of clinical research studies across study start-up, conduct, and site management.
• Built and developed high-performing teams through recruitment, training, line management, and resource planning.
• Provided leadership across governance, compliance, stakeholder engagement, and problem-solving to support delivery to quality, timeline, and accrual goals.

Represented the unit at governance and collaborative forums , while driving continuous improvement and quality initiatives

• Provided global clinical scientist leadership across site strategy, CRA oversight, and study execution to support consistent delivery and quality.
• Responsibilities:
• Led site budget and contract discussions and supported country-level regulatory, ethics, and research submissions.
• Drove study and therapy area training for CRAs and local teams, while providing strategic input on country-specific issues to the global team.
• Supported inspection readiness and audit preparation, including for MHRA inspections.
• BI awards: MHRA Government Inspection experience
• Q1 2011 Winner Team for outstanding professionalism and persistence in ensuring that the MHRA GCP inspection of Emergency CVS study received no critical or major findings (January 2011). BI Clinical Research Reward & Recognition Scheme.
• Q3 2010 Winner Team for great job in preparation for inspection (September 2010). BI Clinical Research Reward Recognition Scheme.

Senior Clinical Project Manager – Cardiovascular, Phase II/III/IV

• Led site, contract, and vendor management across large-scale European cardiovascular studies.
• Directed study start-up and operational design , including CRF development , monitoring strategy , and cross-functional collaboration with Statistics, Medical, and Data Management .
• Led and developed a multi-country CRA network across five European CROs and supported continuous improvement in operational processes.

• Set up study feasibility, completed site assessments across clinical centres in-person.
• Prepared investigator and centre-specific files to support document readiness.
• Designed protocol PIs and CRF templates to align data capture consistently.

• Lead/Senior CRA (team of 12) in the clinical investigation of an antimigraine drug given for the acute treatment of Migraine (A multicenter study - 150 sites in twenty countries, to involve a total of 1,600 patients – phase III).
• Responsibilities:
• Study feasibility, set-up, and site assessment.
• Preparation of investigator/centre specific files.
• Protocol, PIS and CRF design.
• Pre-Trial monitoring, initiation, and termination visits.
• Mentoring and training of CRAs.
• Monitoring and site management across Europe and South Africa.

• Project Leader & Monitor in the clinical investigation of an antifungal drug in high-risk patients undergoing liver transplantation.
• Responsibilities:
• Assure the protection of the rights, safety, and wellbeing of human study subjects.
• To analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.
• Identify & assist in the study site selection process, initiate, and eventually close out clinical study sites.
• To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
• To make certain that the scientific integrity of the data collected is protected and verified.
• Assure that adverse events are correctly documented and reported.
• Review all case report forms and compare them to source documents.

• Co-Ordinator in the clinical investigation of antithrombotic drugs in patients with unstable angina, anti-inflammatory drugs in patients with gastrointestinal disease and of angiotensin II antagonists in patients with hypertension.
• Responsibilities:
• To conduct clinical trials at Irish Hospital/research sites according to the protocol, ICH-GCP and other regulatory requirements.
• Administrative assistant to the convenor of the Ethics Committee in Beaumont Hospital, Ireland.
• Check inclusion and exclusion criteria thoroughly before randomization, and only then organize for enrollment for Enter data in case report forms (CRF) after completion of all visit procedures.
• To keep Investigator Site File up to date and maintain site SOP's, EC sops and EC members list.
• Calculate study drug accountability.
• Storage of IP (Investigational product) in proper condition and maintain required temperature logs.
• Report any adverse events (AE's) or serious adverse events (SAE's).

• Provide care for patients with life-threatening medical conditions, e.g., patients who have experienced invasive surgery, accidents, trauma, or organ failure.
• Responsibilities:
• Provide careful assessment and monitoring of patient progress to watch for sudden or subtle changes in a patient's medical condition that might require emergency intervention.
• Provide respiratory and heart monitoring as well as treatment adjustments.
• Manage medication doses, anesthesia and ventilatory support.
• Nursing awards:
• Highest academic grade in Biological Science during Intensive Care postgraduate course, UCL London. Awarded two highest academic prizes' during RGN training: Chief Executive officer prize for the best academic performance during my first and final year.