Senior Clinical Study Manager Global Trials Leader

CURRICULUM VITAE

Joan Puchalski

***********@*******.***

Education:

Rutgers Graduate School of Management, Piscataway, NJ

MBA, May 1996

Rutgers College, New Brunswick, NJ

BA, Biochemistry

Implementation of global regulatory compliant research within pharmaceutical, CRO and Biotech organizations

Expertise in planning and executing global Phase I-IV clinical trials in Oncology, Cardiovascular Disease, Infectious Disease,

Metabolic Disease, Immunology/Rare Disease, Cardiopulmonary Disease, Renal Disease and Women’s Health

Adept in executing clinical trial development plans and addressing related regulatory issues

Dynamic, innovative leader with experience in clinical research, operations, study management and recruitment acceleration

Proven track record of effectiveness in a multidisciplinary, matrix team environment

Excellent stakeholder management skills, with a predisposition towards collaborative process improvement

PROFESSIONAL EXPERIENCE:

Sr. Clinical Study Manager - BeOne, Hopewell, NJ (Oct 2025 - Present)

Accountable for regional study delivery and inspection readiness within timelines and budget

Regional lead for global Phase III oncology clinical trial

Lead clinical operations team and serve as point of escalation for issue resolution

Collaborate with key stakeholders and provide regular updates on study progress to senior management

Represent regional study team at internal meetings and lead cross-functional Clinical Study Team meetings

Lead study planning and management including feasibility, start-up, maintenance, data cleaning, final analyses and closeout

Generate, manage, and maintain high quality study start up and recruitment timelines and track and report progress

Prepare local adaptations of global study documents, ensuring submission to regulatory authorities and ECs/IRBs

Ensures information in study systems is entered and up to date, including CAPAs, protocol deviations, and issues and actions

Collaborate with regional CRAs to ensure proper study execution at sites; review and sign-off monitoring reports

Ensure country and site level TMF is created and maintained with QC conducted on a regular basis per TMF plan

Collaborate with CRAs and sites to manage data collection, driving timely data entry and query resolution

Manage escalated issues with the sites, evaluating impact and ensuring solution implementation

Monitor study activities to ensure compliance with study protocol, SOPs, ICH/GCP and all other regulations

Prepare sites for quality assurance audits and inspections, driving responses to audit and inspection findings

Work with the sourcing team to select and manage regional study vendors

Manage regional study budgets and work with Clinical Business Operations to ensure timely site payments

Clinical Trial Manager - Karyopharm Therapeutics, Newton, MA (Jan 2024 - Apr 2025)

Responsible for operational aspects of planning, implementation, management and tracking of clinical trial activities

Ensure quality and completion of clinical trial deliverables per budget and timelines including CROs and vendor management

Tracking and reporting on study progress from start-up through close-out, escalating issues as needed

Review and contribute to preparation of Data Safety Monitoring Board updates, protocol amendments and ICFs

Assist with preparation of site and CRA training materials; oversee monitoring activities and facilitate CRA meetings

Conduct clinical review of CRFs and IRT UAT and creation of study specific eCRF completion guidelines

Responsible for content, accuracy, and maintenance of study files (TMF, etc.) and inspection readiness

Work with Clinical Supplies and Central Lab to ensure sites are provided study required supplies

Conduct protocol deviation review and lead Protocol Deviation Review Meetings

Clinical Project Manager - Syneos Health, Morrisville, NC (Mar 2020 - Dec 2023)

Manage study start-up, maintenance and closure of multiple myeloma and pediatric cGVHD global clinical trials

Prepare protocol amendments, study plans, manuals, newsletters and training materials for study team, sites and vendors

Create Study Country Questionnaire (SCQ) and Site Survey Questionnaire (SSQ) to facilitate country and site selection

Lead clinical operations and cross-functional team meetings, provide updates to stakeholders and update CTMS

Participate in vendor/CRO selection, SOW development and management/oversight including timelines and budget

Lead process improvement initiative, facilitating Acceleration Operations Meetings, serving as Recruitment Acceleration Liaison

Assist with management of Patient Advocacy Group vendors, including creation of a Patient Advocacy Group Brochure

Manage transition of study sites in Russia from CRO to Sponsor, requiring extensive cross-functional collaboration

Conduct protocol deviation review and management and conduct internal and CRO TMF review

Senior Clinical Trial Manager - Angion Biomedica Corp, Uniondale, NY (Jul 2019 - Mar 2020)

Manage CROs and vendors, providing oversight to ensure adherence to defined scope of work, timelines and budget

Prepare operational plans and manuals, including Operations Manual, Safety Plan, Project Management Plan,

Communication and Sponsor Oversight Plan, Pharmacy Manual, Protocol Deviation Plan and Risk Management Plan

Track study progress and metrics, ensuring timely data collection, monitoring and data cleaning activities

Proactively identify, resolve and escalate issues that may jeopardize clinical study completion on time and within budget

Provide senior management with regular study updates and status reports regarding study execution and metrics

Prepare study documents, including protocols, amendments, clarification letters, study plans and timelines

Develop and maintain tracking of study status, monitoring, lab samples, data entry, issues log, action items and FAQs

Clinical Trial Manager - Ferring Pharmaceuticals, Parsippany, NJ (Oct 2018 - Jul 2019)

Responsible for clinical trial delivery within timelines and budget, in compliance with GCPs, SOPs and quality standards

Study plan development, including Safety Monitoring Plan, DSMB Plan, Trial Risk Management Plan, Protocol Deviation

Plan and Vendor Specifications and Oversight Plan

Oversight of DSMB, Steering Committee Activities, audit/inspection readiness and CAPA preparation

Coordinate and oversee internal/external resources and vendors to ensure impeccable study execution

Prepare study materials, manage clinical sites and vendors and identify risks and prepare risk mitigation strategies

Lead site selection, management, vendor evaluation, development and review of SOW, budget and change orders

Provide oversight and preparation for internal and external audits/inspections and FDA pre-approval inspections (PAI)

Conduct ongoing study analytics review, analysis and reporting to identify trends and risks; escalate and address issues

Serve as Data Management Lead, providing training, medical data review, query generation, and metrics reporting

Project Manager, Clinical Operations - PhaseBio, Malvern, PA (Jul 2018 - Oct 2018)

Lead internal and outsourced site management and monitoring personnel and activities to ensure timelines and deliverables

are met within budget, ensuring site management integrity, quality and timeliness of monitoring activities

Create and maintain protocol Risk Assessment and Characterization Tool (RACT), oversight and approval of monitoring plans,

and coordinate monitoring activities, including leading issue management meetings and inspection readiness activities

Provide leadership and content expertise for site management and monitoring activities from study start-up through close-out,

providing oversight of resources, timelines, quality and data delivery to support database lock

Senior Clinical Project Manager - Hengrui Therapeutics, Princeton, NJ (Nov 2017 - Jul 2018)

Manage clinical project planning and execution including management of timelines, budgets and deliverables

Conduct study tracking and prepare status updates, conduct data gathering and metrics reporting

Coordinate, facilitate and lead team meetings, escalate and resolve issues, track and mitigate risks, ensure goals and

deliverables are clearly defined, and that issues, decisions, risks and action items are appropriately tracked and managed,

and conduct contingency planning and resource management

Responsible for leading cross-functional project team in planning and delivery of Phase I clinical trials, including CRO and

vendor management, in accordance with scope, quality, budget and timeline requirements, and managing resources, risks,

and quality in compliance with SOPs and ICH/GCP guidelines

Manage vendors, CROs and functional contractors, including negotiation of scope of work, budgets, change orders, detailed

invoice review and payment, performance management and issue resolution

In collaboration with the Medical Director, analyze and develop action plans and escalate safety issues, patient care issues,

and study design and/or conduct issues

Develop key study documents including protocols, amendments, administrative letters, study plans and procedure manuals,

project tools, ICFs, clinical study report and Advisory Board Meeting presentations

Prepare and present clinical study updates for management and lead SOP development and TMF reconciliation

Medical Advisor Researcher - InVentiv Health, Bridgewater, NJ (Jul 2017 - Oct 2017)

Assist Medical Advisors (MAs) in scientific and operational contribution to Pre-Assessment and Operational Feasibility

process and site selection, identifying process improvements in implementation of feasibility tools and interfaces with new

partners, including Medical Affairs, to reduce the number of low-enrolling sites

Create training material related to Pre-Assessment/Operational Feasibility, site selection and recruitment projections

based upon review of extended synopsis, draft protocol and other study documents

Formulate feasibility response based on feasibility questionnaires, site teleconferences and stakeholder feedback

Collaborate with MAs to establish and improve list of investigators, KOLs & Consortia for each therapeutic area

Prepare response to Pre-Assessment/Operational Feasibility and submit to Feasibility Manager

Assist MAs in educating internal departments on pre-assessment, operational feasibility and site selection process

Senior Clinical Scientist - ExecuPharm, King of Prussia, PA (Feb 2016 - Jul 2017)

Responsible for clinical and scientific execution, conduct and implementation of global oncology clinical protocols in

melanoma, including facilitating Investigator Meetings by preparing slides and providing training, ongoing training of site staff,

safety and medical data review, and executing on study deliverables from start-up through close-out

Responsible for vendor management and oversight, including timelines, budget and quality

Write protocol clarification letters and assist in authoring protocols and amendments

Prepare all study manuals and plans (i.e., Procedures Manual, Pharmacy Manual, Site Monitoring Plan, and Protocol

Deviation Review Plan) and prepare annual IRB updates

Provide support for publication/acknowledgement for critical review for article in the Journal of Clinical Cancer Research

Lead cross-functional team meetings including external partners, NCI and ECOG

Review and classify protocol deviations and reconcile imaging data and lab data and reconcile patient status in IVRS vs. EDC

Key contact for all scientific and clinical questions from sites and field staff regarding the protocol and patient eligibility

Ensure data integrity via medical data review, identification of trends, signals and discrepancies, writing and resolving queries

Senior Strategic Recruitment Lead, Global Recruitment & Analytics - BMS, Lawrenceville, NJ (Jun 2013 - Feb 2016)

Develop Patient Recruitment, Retention and Engagement Toolkit by attending vendor conferences and in-house vendor capabilities presentations to assess and rate vendor capabilities, creating a toolkit for utilization by clinical study teams

Develop patient portal microsites to prepare patient-friendly on-line screeners for critical inclusion/exclusion criteria

Implement recruitment, retention and patient engagement strategies, via collaboration with advocacy organizations and

identifying and vetting appropriate vendors, including serving as SME for Greenphire ClinCard for patient reimbursement and travel needs, home healthcare vendors, EMR/HER vendors, and patient communities to enhance patient experience and improve patient engagement, compliance and retention for better study outcomes and data quality

Implement digital recruitment plan, including geo-targeted SEM and patient portal for screening, site referral and enrollment

Implement patient-facing clinical trial mobile app to improve clinical trial patient engagement, retention and compliance

Provide training and support for recruitment, retention and engagement strategies, including Patient Retention Checklist,

referral letters, Site Reimbursement Form, mini protocols, inclusion/exclusion cards, site and patient-facing Schedule of Activity Cards, educational brochures, study posters, on-line banner ads, and Lost to Follow-Up Packet to reduce LFU patients

Develop and implemented program and study level clinical trial recruitment, retention and patient engagement strategies for

15 protocols across therapeutic areas by researching the patient journey to identify challenges, through discussions with KOLs, assessing competitive and regulatory environment, reviewing country and site metrics and historic data, reviewing incidence and prevalence data, exploring patient communities and collaborating with advocacy organizations

Assess site and country feasibility and conduct recruitment modeling using analytics data, feasibility questionnaires and

reviewing openpaymentsdata.cms.gov for US sites, as an indication of potential Investigator’s recent research performance/

activity, to select appropriate sites and countries and to ensure protocol design is feasible for both sites and patients,

while incorporating required data points

Prepare cohort and study tracking reporting, facilitating target setting and hub commitments

Utilize and integrate analytic inputs and advocacy and health disparity strategies in developing recruitment, retention and

patient engagement strategies, and manage Global Recruitment and Analytics budget for each protocol

Facilitate global team meetings and work streams related to recruitment and retention across therapeutic areas including

immunology, virology, metabolic disease and oncology

Senior Lead Site Manager - Bristol-Myers Squibb, Lawrenceville, NJ (Aug 2005 - Jun 2013)

Provide leadership to global Site Managers, as Sr. Lead Site Manager for Hepatocellular Carcinoma Program

Conduct clinical and operational planning, feasibility and execution of global clinical trials through study completion

Develop the Data Review Plan and conduct medical data review using J-Review, lead data review meetings and provide

training for Site Managers to identify trends, signals and issues, including writing and resolving queries in preparation for interim and final database locks and writing protocol amendments, if indicated based on identified data trends

Plan, coordinate and implement Site Rejuvenation Meetings to share best practices to meet enrollment goals

As Central Laboratory and IP Liaison, implemented process improvements, to reduce shipping and IP costs by optimizing

IP shipment and utilization and reducing waste due to lab kit expiration

Facilitate meetings with Clinical Contracts and Grants to build collaborative/cohesive teams, to review the status of

outstanding budget issues, to prioritize activities and to review the status of each site with the STMs, to ensure prompt

resolution of budget/contract issues, and reduce study start-up timelines

Review trip reports, following all issues to resolution and ensuring TMF audit readiness

Pilot PMF Toolkit for study status tracking and risk/contingency planning

Identify study issues, determine resolution, escalate as appropriate, prepare CAPAs, maintain FAQ and Issues Log

Develop clinical documents and plans, including Protocols, Amendments, Administrative Letters, ICFs, patient diaries,

eCRF Guidelines, Protocol Deviation Review Plan, Laboratory Manual, Monitoring Plan, Data Review Plan and Safety

Monitoring Plan and RACT, to ensure protocol quality standards are met from study start-up through database lock

Project Manager, Clinical Operations - Covance, Princeton, NJ (Jan 2004 - Aug 2005)

Conduct feasibility assessments, prepare presentations for bid defenses and present at Bid Defense Meetings

Develop and implement project plans, budgets, timelines and resource projections and planning

Lead team in study planning and execution from feasibility through close-out, including preparation of protocol

plans and timelines, data management deliverables, country/site selection, system updates, Investigator Meeting planning

and presenting, status reporting, risk identification/escalation/mitigation, quality and safety oversight and audit readiness

Serve as primary Sponsor contact and supervise all clinical trial activities to meet timelines, budgets and performance quality,

anticipate project requirements and implement appropriate action plans to meet study milestones

Develop study protocols, CRFs, study manuals and plans, and clinical trial report

Ensure appropriate quality and timely monitoring of sites by the project team and conduct trip report review

Manage clinical follow-up of quality assurance reports and responses to regulatory authorities

Serve as line manager for internal team, providing training to internal staff

Train CRAs, ensure timely monitoring of site visits, conduct co-monitoring visits, PSVs, SIVs, IMVs and COVs

Project Manager, Clinical Operations - Target Research Associates, Philadelphia, PA (Apr 2003 - Jan 2004)

Provide leadership to the project team, including protocol-specific training of in-house and CRA staff

Conduct feasibility, budget, timeline and resource management and execution of a Phase III cardiovascular study

Manage quality and regulatory compliance, risk identification/mitigation and issue resolution

Serve as primary contact for Sponsor, CRAs, study sites, vendors and internal staff

Ongoing review of metrics to ensure study completion according to planned timelines, scope and budget

Clinical Scientist - Quintiles, Inc., Cranford, NJ (Aug 2001 - Apr 2003)

Provide functional line management of clinical staff and serve as primary contact to Sponsor and investigative sites

Plan and manage project start-up, site monitoring, study maintenance and closure, ensuring adherence to ICH/GCP

Prepare and present bid defense proposals, develop protocols, CRFs and ICFs

Lead team in study planning, development and execution, including preparation of study plans and manuals, timeline

development, data management deliverables, country/site selection and CTMS and study status updates

Plan Investigator Meetings, prepare slide deck and present at Investigator Meetings

Provide updates to management, including timelines, budget, risk identification/mitigation and issue resolution

Serve as Lead CRA, conducting PSVs, SIVs, IMVs and COVs, train CRAs, write and review trip reports

Data Manager - Covance, Inc., Princeton, NJ (Aug 2000 - Aug 2001)

Conduct database cleaning of studies in cholesterol reduction, treatment for acute mania, and oncology

Clinical Trial Manager - Hurley Consulting Associates, LTD, Chatham, NJ (Feb 1998 - Aug 2000)

Manage clinical trial for transdermal HRT and Phase IV study to assess risk factors for nosocomial fungal infections

Conduct literature review and data collection for compendium

Clinical Scientist - Bristol-Myers Squibb, Lawrenceville, NJ (Apr 1994 - Feb 1998)

Manage global Phase III clinical trials in Type II diabetes and diabetic nephropathy

Lead SOP Committee Meetings, Investigator Meetings, DMC meetings and CSR meetings

Contribute to journal article regarding angiotensin II inhibitor in mild-to-moderate HTN, in American Journal of HTN

Contribute to authoring protocols, amendments, administrative letters, CSRs, regulatory agency updates and responses

Recruit and select investigators, negotiate contracts and budgets, prepare ICFs and review regulatory documents

Provide training to CRAs and site staff, maintain TMF, monitor and report study progress and ensure inspection readiness

Data Manager - Bristol-Myers Squibb, Lawrenceville, NJ (Apr 1990 - Apr 1994)

Develop CRFs, design and validate databases, and create the Data Management Plan (DMP) and train site staff

Monitor data for compliance, generate queries to resolve discrepancies, and ensure data quality

Lead data review, ensure data consistency across sources (e.g., labs), and finalize databases for statistical analysis

Contribute to CSR preparation and review including safety summaries and safety updates for FDA submission

Therapeutic Area Experience:

Oncology (16 Years: 7 Years Phase I - II; 9 Years Phase III)

Cardiovascular Disease / HTN and HTN with Diabetic Nephropathy (9 Years Phase III)

Infectious Disease (2.5 Years: 6 Months Phase III; 2 Years Phase IV)

Metabolic Disease/Diabetes (1 Year: 6 Months Phase I - II; 6 Months Phase III)

Immunology/Rare Disease (6 Months Phase I)

Cardiopulmonary Disease (2 Months Phase II)

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