Christy Parker
Manakin Sabot
Summary
Clinical operations leader with 20+ years of experience in directing global clinical trials, ensuring regulatory compliance and operational excellence. Proven expertise in developing cross-functional teams that enhance trial performance and mitigate risks. Skilled in managing budgets and resource allocation effectively to achieve project goals.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Sr. Global Project Manager / Associate Director of Clinical Operations
Parker Clinical Consulting
08.2025 - Current
- Supported execution of oncology clinical trials across pharmaceutical and biotechnology organizations while leading clinical operations team.
- Facilitated bid defense meetings in radiopharmaceuticals and oncology therapeutic areas to secure project opportunities.
- Oversaw and completed DBL and all cross-functional activities for study close out through the publishing of the abbreviated CSR.
- Lead eTMF completion to ensure inspection readiness.
- Conducted routine Protocol Deviation and Risk Review meetings.
- Created complex change orders and navigated month-end finance activities while participating in DSMC meetings.
- Developed additional work orders to support the CRO completing the last grant payments.
- Clients: BPGBio and Kintara August – Jan 2026: Oncology Trials, Corbus Pharmaceutical- Jan 2026- Present
Associate Director, Clinical Operations (Oncology)
BioNTech
03.2024 - 04.2025
- Oversaw all phases of clinical trial execution from initiation to close-out while ensuring regulatory compliance, adherence to ICH-GCP guidelines, and operational excellence.
- Managed trial budgets, tracked deliverables, and coordinated cross-functional activities to ensure alignment across departments and external partners.
- Led the preparation and quality assurance of core trial documents, including protocols, monitoring manuals, trial plans, and patient-facing and site recruitment and retention materials.
- Supervised clinical operations teams (unblinded and blinded) and ensured consistent training and procedural compliance.
- Facilitated investigator meetings and bid defense preparations, supported site selection processes, negotiated site contracts, and ensured audit and regulatory inspection readiness.
- Executed site selection processes to enhance site activation speed, achieve enrollment targets, and strengthen investigator engagement.
- Prevented operational delays by intervening in planning variances and initiating timely mitigation actions.
- Managed legal coordination for clinical contracts, securing timely approvals across stakeholders with a large geographical footprint.
Associate Director, Clinical Operations Lead – Infectious Disease (COVID & RSV)
Moderna Therapeutics
04.2022 - 03.2024
- Oversaw global execution of a fast-paced clinical program encompassing multiple concurrent Phase I–III trials focused on COVID and RSV.
- Delivered time-sensitive global trials across three clinical phases, achieving critical milestones ahead of schedule.
- Formulated and implemented operational plans aligned with development strategies, contributing to accelerated vaccine candidate progress.
- Translated asset strategy into clinical operations plans by collaborating with Clinical Development.
- Directed cross-functional team coordination to enhance timelines and streamline operational execution.
- Supervised internal and outsourced teams to ensure protocol compliance, site activation, and data quality.
- Monitored budget planning, resource allocation, and program expenditure to ensure alignment with strategic goals.
- Governed vendor selection, contract negotiation, and operational delivery to optimize performance and compliance.
- Improved vendor performance by refining oversight protocols and introducing performance tracking metrics.
Local Study Associate Director (LSAD/ADCR), Immuno-Oncology
AstraZeneca Pharmaceuticals
01.2019 - 03.2022
- Managed operational delivery of clinical trials at the country level within the Immuno-Oncology portfolio.
- Achieved consistent delivery of study milestones by aligning site activation and monitoring timelines with strategic study goals.
- Supervised and coached clinical research staff, including CRAs and CSAs, while coordinating study start-up, site monitoring, and study close-out.
- Allocated resources, monitored team performance, and ensured adherence to ICH-GCP, AZ procedures, and local regulations.
- Supported site selection, regulatory submissions, risk management, feasibility assessments, and eTMF maintenance.
- Enhanced data quality through proactive monitoring oversight and implementation of corrective action plans.
- Streamlined ethics submission and regulatory approval processes to minimize site initiation delays.
- Reviewed visit reports, coordinated national investigator meetings, and facilitated local study team communications to enhance collaboration.
- Supported continuous improvement initiatives, contributing to enhanced local and global clinical operations procedures.
Clinical Team Manager
PPD
Midlothian
05.2017 - 09.2018
- Managed clinical resources (CRAs/administrative team) according to projections of ongoing clinical activities to ensure maximum resources are allocated to maintain forward movement of clinical deliverables.
- Executed project deliverables within contractual timelines and client expectations across all trial phases (start-up, recruitment, maintenance, close-out-database lock).
- Led coordination and management of PPD-customer joint project team through start-up, conduct, tracking, quality assurance, regulatory compliance, and close-out activities.
- Oversaw risk-based monitoring (RBM) activities and clinical budget, escalating out-of-scope activities for contract modification consideration.
- Managed contingency planning for data cleaning; clinical data listings review; and, coordinated process for reviewing data listings by clinical team.
- Prepared monitoring plan and implemented standardized clinical monitoring processes within the study team.
- Oversaw the development of source documents, CRF/eCRF guidelines and other project-specific forms to be utilized during the study period.
- Participated in site recruitment and budget negotiations.
- Performed secondary clinical review of case report forms for the purposes of discovery of query trends and CRA re-education.
- Reviewed essential regulatory documents prior to transmittal to the client for release of initial investigational product.
- Presented research findings at investigator meetings to enhance understanding of study objectives.
- Midlothian, VA
Sr. Project Manager
InVentiv Health
Midlothian
02.2016 - 05.2017
- Led phase II rare disease severe asthma project across 17 countries and 2 multiple sclerosis projects, ensuring alignment with global regulatory requirements.
- Worked cross functionally to ensure all key milestones and deliverables are met on time and with quality.
- Managed the country level budget (US) for all project budgets.
- Ensured feasibility, screening and enrollment projections are met.
- Onboarded and trained new team members in Clinical Study Unit, enhancing team capability and project readiness.
- Conducted Quality Oversight Visits to ensure CRA performance and build PI/ site staff rapport for Sanofi relationship management.
- Oversaw creation of PSSV, SIV, IMV, and COV materials and processes, streamlining documentation for project compliance and efficiency.
- Launched a voucher card program to supply background medications for projects.
- Midlothian, VA
Senior Clinical Research Manager
Altria Client Services
Richmond
05.2014 - 10.2015
- Oversaw CROs in clinical management of studies, including pharmacokinetics and short-term in-clinic and ambulatory long-term studies, supporting Modified Risk Tobacco Applications (MRTP) and FDA inquiries.
- Oversaw Clinical Research Associate consultants, a clinical coordinator, a bio analytical lead, and a clinical operations manager for day –to- day tasks and decision-making.
- Collaborated cross-functionally with procurement on CRO RFPs, MSAs, third-party vendor selection, and site contracts; partnered with product development on test product studies, finance on vendor invoices, and product integrity on protocol design.
- Managed and tracked all study deliverables and managed internal team deliverables (office project).
- Hosted and oversaw RFP/ CRO selection meetings.
- Strategized with team to ensure all timelines were on target for FDA submission.
- Built infrastructure to support increase in study volume and ensure ICH/ GCP compliance was met.
- Conducted site feasibility visits to ensure adequate facilities for each type of studies required for site selection/ participation.
- Ensured program-level tracking of key milestones to maintain accuracy and facilitate risk mitigation.
- Managed all clinical monitoring related tasks, deliverables, etc. for all studies.
- Assisted in creating SOPs and working practices.
- Richmond, VA
Regional Clinical Operations Leader (COL) Manager
PAREXEL Inc.
Richmond
07.2013 - 05.2014
- Led 15-25 Clinical Operations Managers (Clinical Trial Managers) to achieve successful project outcomes.
- Ensured timely and quality completion of project deliverables and milestones.
- Oversaw performance reviews and development programs for direct reports to enhance team capabilities.
- Richmond, VA
Clinical Trial Leader/Clinical Trial Manager
INC Research
Richmond
09.2012 - 02.2013
- Provided comprehensive oversight of operational aspects of assigned clinical trials, including the preparation and/or review/approval of study-related documents (e.g., Laboratory Manual, Patient Reported Outcomes, Pharmacy Manual, Case Report Form Completion Guidelines, etc.).
- Coordinated Clinical Research Organization (CRO) interactions, overseeing sponsor-related activities such as study management, monitoring, site management, project master files, and data management.
- Collaborated with CRO to develop and revise scope of service agreements, budgets, and project plans, ensuring alignment with performance expectations.
- Managed project training for global programs for specific Sponsors.
- Supported hiring, onboarding, and line management of CRA contractors while managing assignment of SWAT resources for PSSVs.
- Richmond, VA
Lead Clinical Research Associate (CRA)/Clinical Trial Manager (CTM)
OPTUMInsight (UHC)
10.2011 - 09.2012
- Led clinical oversight for multiple project teams across various therapeutic areas.
- Collaborated remotely with teams to drive project milestones and ensure timely progress.
Manager, CRA (Clinical Research Associate) Manager of Clinical Operations
PRA International
Richmond
08.2010 - 09.2011
- Managed 15-25 CTMs/ CRAs/ In-House CRA's.
- Assessed clinical operations and employee resources to ensure project teams met client expectations and PRA contractual obligations.
- Implemented performance and productivity improvements to optimize utilization of billable staff.
- Managed operational budget within respective budget guidelines.
- Guided clinical operations and contingency planning to accommodate project-specific nuances.
- Interfaced with clinical staff across PRA business units, providing input and feedback to promote quality deliverables.
- Richmond, VA
Regional CRA Manager
i3 Research, (UHC)
02.2008 - 06.2010
- Regional Manager managed a team of 15-25 CRAs/ In House CRAs/ Lead CRAs.
- Ensured compliance in training and development of direct reports.
- Coordinated project resource allocations and tracked performance metrics.
- Participated in departmental initiatives for increased performance, training and consistency across the Lead CRA team.
- Conducted on site Oversight Visit for performance assessment.
- Approved and reviewed expense reports for accuracy and adherence to budget.
- Worked remotely to facilitate team communication and project management.
Senior Clinical Research Associate/ Lead CRA/ CTM
i3 Research (UHC)
Richmond
07.2006 - 02.2008
- Coordinated clinical tasks across multiple studies to ensure compliance and data integrity.
- Reviewed monitoring reports and managed metrics to enhance study performance.
- Conducted CRA project training and oversight visits.
- Oversaw site audits, addressing findings and implementing resolutions to maintain regulatory standards.
- Conducted report review and managed CRA transitions.
- Location of employment: Richmond, VA
Clinical Study Lead
Otsuka Pharmaceutical
Richmond
08.2005 - 07.2006
- Managed CRO metrics and training, ensuring timely deliverables to Sponsor.
- Conducted CRO and CRA oversight visits.
- Provided project training to CRO CRAs as needed.
- Reviewed reports as Sponsor for CRO CRAs after finalization by CRO.
- Richmond, VA
Senior Clinical Research Associate/ Lead CRA
Ingenix (UHC)
Richmond
09.2004 - 08.2005
- Led team of CRAs to ensure compliance and quality in clinical study execution.
- Supported project management team in coordinating study timelines and deliverables.
- Worked in Richmond, VA
Clinical Research Associate II
Ingenix (UHC)
Cary
04.2002 - 09.2004
- Performed monitoring visits and authored comprehensive reports to ensure site compliance and data integrity.
- Oversaw site audits and followed findings until resolution.
- Conducted site management for assigned sites.
- Managed and updated Q & A Log, facilitating communication and resolution of inquiries for internal and external stakeholders.
- Oversaw operational activities in Cary, NC, ensuring adherence to project timelines and regulatory standards.
Clinical Research Monitor
Parexel International
Durham
12.2000 - 04.2002
- Conducted PSSVs, SIVs, IMVs, and COVs for multiple studies, ensuring compliance and quality in regional clinical trials.
- Managed project team newsletter, facilitating communication and updates to study sites.
- Assisted Primary CRA with project tasks, contributing to overall project efficiency and timely deliverables.
- Durham, NC
In House CRA
PPD
Midlothian
02.2000 - 11.2000
- Acted as In House CRA for Phase IV multicenter study evaluating post-kidney and liver transplant patients.
- Oversaw all site regulatory start-up through Site Initiation to ensure accuracy and completeness.
- Reviewed case report forms remotely to ensure data accuracy and completeness.
- Collaborated with PM to coordinate activities across in-house team and sites, ensuring timely clinical deliverables.
- Coordinated compliance and efficiency activities for over 150 clinical research sites.
- Midlothian, VA
Education
Drug Delivery Overview -
University of North Carolina
Chapel Hill, NC, USA12-2002
Bachelor of Science - Health Promotion
East Carolina University
Greenville, NCBachelor of Science -
Brevard College
Brevard, NCSkills
- Study management
- ICH/GCP compliance
- Patient recruitment
- Submission support
- Vendor management
- Risk mitigation
- Logistics planning
- Resource forecasting
- Document review and reconciliation
- Stakeholder engagement
- Team mentoring
- Amendments and protocols
- Product planning
Affiliations
Association of Clinical Research Professionals, 2002 - 2015
Certification
Certified Clinical Research Associate (CCRA), 2002 - 2015, Association for Clinical Research Professionals
Therapeutic Area Experience
- Infectious Disease: COVID (Phases II–III), Influenza (Phase III), H1N1 (Phase III), RSV (Phases II–III)
- Immuno-Oncology: NSCLC (Phases II–III), Small Cell Lung Cancer (Phases II–III), Pancreatic Cancer
- Central Nervous System: Anxiety, Bipolar Disorder, Schizophrenia (Phases II–IV; inpatient)
- Rare Diseases: Severe Asthma (Phases II–III)
- Cardiovascular: CABG (Phase III), Hypertension (Phases II–III)
- Post-Transplant: (Phase IV)
- Seasonal Allergy: (Phases II–III)
- Women’s Health: PCOS, Hormone Replacement Therapy (Phases II–III)
- Ophthalmology: (Phases II–IV)
Global Experience
Oversight and execution of clinical trials across North America, Europe, Asia-Pacific, and Latin America, including regulatory and operational leadership in diverse geographic regions.
System Experience
- Veeva eTMF
- Quality and Document Management
- Microsoft Office Project and Office
- RAVE EDC
- IRT/ IVRS
- ECOA
- CTMS
- Smart Sheet
- BRIMs Regulatory Document Management System
Professional Development
Drug Delivery Overview, University of North Carolina, Chapel Hill, NC, USA, 2002
Professional Highlights
- Successfully led the first Phase III UK based COVID Omicron variant clinical trial from start up through CSR.
- Successfully led a NSCLC Phase III trial during the COVID pandemic in 3 countries with very limited lab and ancillary supplies.
- Proven track record managing teams in a matrix environment to ensure quality compliance, milestone management, career development and overall top performance.
Timeline
Sr. Global Project Manager / Associate Director of Clinical Operations
Parker Clinical Consulting
08.2025 - Current
Associate Director, Clinical Operations (Oncology)
BioNTech
03.2024 - 04.2025
Associate Director, Clinical Operations Lead – Infectious Disease (COVID & RSV)
Moderna Therapeutics
04.2022 - 03.2024
Local Study Associate Director (LSAD/ADCR), Immuno-Oncology
AstraZeneca Pharmaceuticals
01.2019 - 03.2022
Clinical Team Manager
PPD
05.2017 - 09.2018
Sr. Project Manager
InVentiv Health
02.2016 - 05.2017
Senior Clinical Research Manager
Altria Client Services
05.2014 - 10.2015
Regional Clinical Operations Leader (COL) Manager
PAREXEL Inc.
07.2013 - 05.2014
Clinical Trial Leader/Clinical Trial Manager
INC Research
09.2012 - 02.2013
Lead Clinical Research Associate (CRA)/Clinical Trial Manager (CTM)
OPTUMInsight (UHC)
10.2011 - 09.2012
Manager, CRA (Clinical Research Associate) Manager of Clinical Operations
PRA International
08.2010 - 09.2011
Regional CRA Manager
i3 Research, (UHC)
02.2008 - 06.2010
Senior Clinical Research Associate/ Lead CRA/ CTM
i3 Research (UHC)
07.2006 - 02.2008
Clinical Study Lead
Otsuka Pharmaceutical
08.2005 - 07.2006
Senior Clinical Research Associate/ Lead CRA
Ingenix (UHC)
09.2004 - 08.2005
Clinical Research Associate II
Ingenix (UHC)
04.2002 - 09.2004
Clinical Research Monitor
Parexel International
12.2000 - 04.2002
In House CRA
PPD
02.2000 - 11.2000
Drug Delivery Overview -
University of North Carolina
Bachelor of Science - Health Promotion
East Carolina University
Bachelor of Science -
Brevard College