Joby Mathew ad401l@r.postjobfree.com • LinkedIn

Downingtown, PA 19335 • 443-***-****

Senior Clinical Trial Manager

Analytical and resourceful leader with 12+ years of experience spearheading complex clinical trials and research projects from inception to completion within defined time, budget, and quality constraints to ensure accomplishment of best outcomes. Well-versed in navigating regulatory environments and following strict compliance with industry best practices, standards, and guidelines. Adept at coordinating operational aspects, negotiating site budgets, facilitating protocol development, and ensuring compliance with strict regulations. Proficient in writing and approving clinical project deliverables, maintaining audit readiness, and overseeing project team members for seamless execution of daily activities. Strategic thinker with an in-depth understanding of clinical trial processes, bringing a proactive approach to risk assessment and problem-solving with a keen focus on ensuring high-quality results across challenging environments. Known for interacting with cross-functional teams and offering support in preparing submission plans and documentation. Talented at establishing enduring relationships with all levels of management and potential stakeholder teams. Areas of Expertise

• Project Lifecycle Planning & Leadership

• Clinical Research Trial File Management

• KPIs & SOPs Development & Execution

• Clinical Study Planning & Supervision

• Team Building, Leadership & Training

• Budget Negotiation & Management

• Quality Management & Clinical Finance

• Regulatory Compliance & Guidelines

• Data Analytics & Management

• Complex Reporting & Documentation

• CRO & Vendor Management

• Stakeholder Engagement

Career Experience

Senior Research Program Manager, Johns Hopkins University, Baltimore, MD 2022 – Present Formulate and deliver appropriate project across multiple study projects in close collaboration with principal investigators as a key member of division leadership team. Offer strategic support to research groups to facilitate grant and IRB application submissions. Oversee project plans development activities and daily work efforts to identify and address issues promptly. Support investigators in deriving insights from performance-based data. Actively engage in scientific discussions with collaborators and funding organizations to make independent decisions on research aims and study design. Interact with principal investigators and funding organizations along with authority to make independent decisions about research aims and study design. Present charters and project plans to governance bodies to generate reports and deliver presentations. Direct weekly meetings with research program management and meet with divisional leadership to discuss resource availability and prioritization of protocols.

● Completed 26 successful complex and/or multiple projects in parallel at Hopkins and pioneered multi-disciplinary team collaborations for driving scientific discussions and heading contributions to seven papers.

● Met set targets and milestones by interacting with SSU team and site investigators via proper administration of on-site.

● Devised and deployed advanced project management tools for timely and budget-compliant project delivery.

● Oversee the vendors, consultants, and CROs, collaborating closely with Procurement to establish performance and quality metrics.

● Tracked KPIs, achievements, risk, mitigation plans and facilitated meetings between stakeholders and leadership.

● Designed and employed effective SOPs as required and contributed to study auditing and monitoring plans. Research Program Manager, Johns Hopkins University, Baltimore, MD 2019 – 2022 Coordinated budget creation and provided financial oversight through collaboration with diverse teams. Hired, trained, and supervised research personnel in the Lung and Heart Transplant Unit of Pulmonary and Critical Care division. Served as the primary point of contact for Dr. Pali Shah, Dr. Sean Agbor-Enoh, Dr. Christian Merlo, and Dr. Jonathan Orens, facilitating communication with various stakeholders such as contract

& grants analysts, site managers, study sponsors and regulatory authorities. Led departmental operations and established rapport with physicians, sponsors, clinics, laboratories, IRBs, and finance offices. Ensured adherence to strict regulatory compliance by overseeing protocol Page 2

approval processes. Monitored project progress, assessed resource allocation, and provided regular updates to management. Maintained a system to track and report milestones for financial invoicing within program.

● Orchestrated timelines and deliverables by establishing and promoting a culture of accountability among team members for consistently accomplishing crucial milestones and objectives.

● Drove efficiency and followed compliance with rigorous standards by pioneering creation of study protocols for submissions.

● Researched and implemented effective SOPs for clinical protocols for timely submission of protocols regarding clinical trials.

● Assessed staff workloads and fostered collaboration between hospital and university personnel for project planning, while organizing site initiation visits and addressing conflicts for retaining positive outcomes. Senior Research Program Coordinator, Johns Hopkins University, Baltimore, MD 2015 – 2019 Directed clinical research activities, such as data collection, record maintenance, and regulatory compliance. Negotiated and approved budgets with sponsors and ensured smooth protocol operation to meet timelines. Enabled seamless communication across multiple sites, investigators, and clinics. Carried out comprehensive protocol reviews and data collection discussions with site managers and study monitors. Managed payments and documents for study-related trials.

● Executed performance appraisals, contributed to staff evaluations, presented project plans, and directed meetings with research management, while supervising workspace allocation.

● Supervised complex projects from inception to completion within strict deadlines and budget constraints.

● Implemented policies, oversaw recruitment, and conducted meetings for clinical trials. Clinical Research Coordinator, FyMed, Inc., Wilmington, DE 2012 – 2015 Provided viable support to staff in coordination of clinical research projects and ensured compliance with regulatory standards, including FDA regulations and Institutional Review Board (IRB) requirements. Maintained up-to-date study documentation, like study protocols, case report forms, and regulatory documents.

● Communicated effectively with study participants, investigators, sponsors, and other stakeholders. Education

Master of Science, Towson University, Baltimore, MD Bachelor of Science, Rajiv Gandhi University of Health Science, India Certifications & Training

● Good Clinical Practice

● Human Subject Research Certification

● Clinical Research Billing Orientation

● Clinical Research Management Systems

● Conflict Interest and Commitment

● Clinical Research Professional Certification

● HIPAA for Research

● Procurement in Research

Affiliations

● Beta Gamma Sigma Honor Society, Member

● Society of Clinical Research Associates, Member

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Technical Proficiencies

MS Office, SAP, Box, Clinical Research Management System (CRMS), Oncore, Electronic Data Capture (EDC), Medidata Rave, Inform, Remote Data Capture (RDC), Intralinks, PHT Systems, Trial File Management System (TMF), IND Submissions, PowerPoint, Keynote & Exhaustive Word

Publications

● Permpalung, Nitipong., Bazemore, Katrina., Chiang, Teresa Po-Yu., Mathew, Joby., Barker, Lindsay., Saman, Nematollahi., Cochran, Willa., Sait, Afrah S., Avery, Robin K., Shah, Pali D. “Impact of COVID-19 on Lung Allograft and Clinical Outcomes in Lung Transplant Recipients: A Case-control Study (2021)”.

● Permpalung, Nitipong., Sait, Afrait S., Bazemore, Katrina., Avery, Robin K., Mathew, Joby., Shah, Pali D. “Human Metapneumovirus and Parainfluenza Virus Infections in Lung Transplant Recipients: The Effects on Lung Allograft and Clinical Outcomes (2021)”.

● Keller, Michael., Bush, Errol., Diamond, Joshua M., Shah, Pali., Mathew, Joby., Brown, Anne W., Sun, Junfeng., Timofte, Irina., Kong, Hyesik., Tunc, Ilker., Luikart, Helen., Iacono, Aldo., Nathan, Steven D., Khush, Kiran K., Orens, Jonathan., Jang, Moon., Agbor-Enoh, Sean. “Use of donor-derived-cell-free DNA as a marker of early allograft injury in primary graft dysfunction (PGD) to predict the risk of chronic lung allograft dysfunction (CLAD) (2021)”.

● Keller, Michael., Mutebi, Cedric., Shah, Pali., Levine, Deborah., Mathew, Joby., Timofte, Irina., Dale, Ross., Dale, Bethany., Woodward, Robert., Giner, C., Varghese, Anu., Agbor-Enoh, Sean. “Biological Variation of Donor-Derived Cell-Free DNA in Lung Transplant Recipients (2021)”.

● Keller M, Mutebi C, Shah P, Levine D, Aryal S, Iacono A, Timofte I, Mathew J, Varghese A, Giner C, Agbor-Enoh. “Biological Variation of Donor-Derived Cell-Free DNA in Stable Lung Transplant Recipients”.

● Bazemore K., Permpalung N, Mathew J., Lemma M., Haile B, Avery R., Kong H., Jang MK., Andargie T., Gopinath S., Nathan SD., Aryal S., Orens J., Valentine H, Agbor-Enoh S., Shah P. “Elevated cell-free DNA in respiratory viral infection and associated lung allograft dysfunction”.

● Keller M., Sun J., Mutebi C., Shah P., Levine D., Aryal S., Iacono A., Timofte I., Mathew J., Varghese A., Giner C., Agbor-Enoh S. “Donor- derived cell-free DNA as a composite marker of acute lung allograft dysfunction in clinical care”.

● Keller M., Yang S., Ponor L., Bon A., Cochrane A., Philogene M., Bush E., Shah P., Mathew J., Brown AW., Kong H., Charya A., Luikart H., Nathan SD., Khush KK., Jang M., Agbor-Enoh S. “Preemptive treatment of de novo donor-specific antibodies in lung transplant patients reduces subsequent risk of chronic lung allograft dysfunction or death”.

● Permpalung N., Liang T., Gopinath S., Bazemore K., Mathew J., Ostrander D., Durand CM., Shoham S., Zhang SX., Marr KA., Avery RK., Shah PD. “Invasive fungal infections after respiratory viral infections in lung transplant recipients are associated with lung allograft failure and chronic lung allograft dysfunction within 1 year”.

● Britton N., Villabona-Rueda A., Whiteside SA., Mathew J., Kelley M., Agbor-Enoh S., McDyer JF., Christie JD., Collman RG., Cox A., Shah P., D'Alessio F. “Pseudomonas-dominant Microbiome Elicits Sustained IL-1β Upregulation in Alveolar Macrophages from Lung Transplant Recipients”.

● Permpalung N., Bazemore K., Mathew J., Gopinath S., Garneau W., Orens J., Nolley E., Merlo C., Barker L., Horn J., Miller S., Miller T., Shoham S., Avery R., Agbor-Enoh S., Shah P. “Comparison of Longitudinal Lung Allograft Function among Lung Transplant Recipients with COVID-19 and Influenza: A Retrospective Study”.

● Charya A., Ponor I., Cochrane A., Levine D., Philogene M., Fu Yi-Ping., Jang M., Kong H., Shah P., Krishnan A., Mathew J, Luikart H., Khush K., Berry G., Marboe C., Iacono A., Orens J., Nathan S., Agbor-Enoh S. “Clinical Features and Allograft Failure Rates of Pulmonary Antibody-Mediated Rejection”.

● Sanders A., Andargie T., Alnababteh M., Charya A., Jang M., Keller M., Mathew J, Aryal S., Kong H., Park W., Berry G., Marboe C., Orens J, Shah P., Nathan S., Valantine H., Agbor-Enoh S. “Cell-free DNA to unveil potential mechanisms of Racial Disparities in Lung Transplant”.

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