Summary
Overview
Work History
Education
Skills
Therapeutic Areas of Experience PH I-IV
Timeline
Generic

Christy Parker

Manakin Sabot,VA

Summary

Global Clinical Operations Expert with Phase 1 – 4 experience including life cycle management. Experience in multiple pharmaceutical and biotechnology settings from the very large to start-up environments with diverse levels of responsibility. Proven track record of excellence in clinical trial management including vendor oversight and financial management. Consistently acknowledged for communication strategy with vendor partners creating a strategic, collaborative relationship. Experienced with strategic planning, project management, and stakeholder communication. Utilizes these skills to enhance operational efficiency and drive team success. Track record of effective leadership in high-stakes environments. Results-driven professional with extensive experience in leadership and strategic oversight. Adept at driving organizational success through effective team collaboration and dynamic problem-solving. Recognized for adaptability and keen focus on achieving objectives. Professional leader with extensive experience in driving strategic initiatives and fostering effective team collaboration. Strong background in project management, budget oversight, and stakeholder engagement, ensuring organizational goals are met efficiently. Known for adaptability, reliability, and focus on achieving impactful results. Skilled in leveraging data-driven insights, optimizing processes, and mentoring teams to excel in dynamic environments.

Overview

6
6
years of professional experience

Work History

Associate Director, Clinical Operations

BioNTech
03.2024 - 04.2025
  • Accountable for senior management level project reporting, inclusive of project delivery timelines, financials, risks and risk mitigation.
  • CRO and major vendors oversight all aspects of project delivery and performance, from start of RFP and contract/SOW development, through project delivery.
  • Leadership of project set-up strategy and planning for multinational trials, inclusive of operational set-up, site vetting and selections, regulatory and ethics submissions globally and per country. Leadership of ongoing total project delivery from start to close-out, to include:
  • Cross functional team management
  • Leadership of project team management and training structure for all clinical operations leads and team members, globally
  • Quality Control of project delivery for all functions, to ensure compliance with regulatory requirements (country and global)
  • TMF compliance and final delivery
  • Lead operational contributions to major key dossier documents: e.g., Protocols, amendments and global consents, Investigator’s Brochure, annual reports, etc.
  • Operational lead for Clinical Development function- support for meetings and trainings.
  • Operational lead for Quality Assurance function: internal or site audits and/or hosting inspections in the scope of a project.
  • DMC and IRC experience
  • Cohort management experience in protocol design requiring dose escalation and optimization
  • Blinding Workstream:
  • Spearheaded the first workstream at BioNTech to develop a blinded/unblinded clinical trial framework: roles and training needed, content of planning documents and process, as the basis for a companywide standard
  • Further developed the unblinded BNT clinical operations role in the Infectious Disease portfolio through work stream meetings, developing required training with our CRO SME’s (ICON and IQVIA) to ensure adequate training and Sponsor Oversight for all trials requiring an unblinded clinical operations team at BNT.

Associate Director, Clinical Operations Lead, Infectious Disease, (COVID & RSV)

Moderna Therapeutics
04.2022 - 03.2024
  • Led the execution of a large, complex and time-urgent global clinical Infectious Disease program which encompassed Phase I, II and III trials in parallel, specifically COVID: ensuring the quality of program regulatory and ethics compliance, risk identification and mitigation.
  • Collaborated with the Clinical Development organization in development of the Clinical Development Plan and the resulting operational strategy, in support of the Asset Strategy.
  • Line Management, including new candidate vetting.
  • Cross- functional team management.
  • Led program budget planning and burning, and external expenditure spending related to program execution, escalation of cost and related delivery issues to senior management.
  • Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, through delivery, with focus on quality and compliance, expenditure control, and risk mitigation.

Local Study Associate Director (LSAD/ADCR), Immuno-Oncology

AstraZeneca Pharmaceutical
01.2019 - 03.2022
  • Provides support and advice on the process of clinical trials as an expert or through the supervision of a local or global team. Recognized expert within own field and often first point of contact for related queries. Will provide process support as an expert or project manager supervising a range of projects.
  • The Associate Director Clinical Research (ADCR) is responsible for delivering the committed part of all clinical interventional trials under their supervision according to agreed resources, and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. The ADCR is responsible for line managing dedicated group(s) of staff such as Clinical Research Associates (CRAs) and/or Clinical Study Administrators (CSAs) and is responsible for planning and utilization of staff resources, objective setting and performance follow-up.
  • As assigned, the ADCR is responsible for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived, as agreed locally.
  • In some countries ADCR may also take responsibilities as Local Study Associate Director (LSAD) if required and agreed with the (Senior) Director, Country Head
  • Accountabilities:
  • Leadership of dedicated groups, building the team spirit, developing team style and behavior.
  • Ensures adequate resources for the trials assigned.
  • Ensures that the workload of direct reports is adequate.
  • Development and performance management of direct reports.
  • Ensures that direct reports have development and training plans, according to IDP process.
  • Coaches the direct reports on a regular basis, and plans/organizes coaching with external providers if needed.
  • Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP.
  • Contributes to efficient SMM organization and its functioning at country level by working closely with responsible (Senior) Director, Country Head.
  • Contributes to high quality feasibility work.
  • Supports successful delivery of SMM study delivery country level targets to plan, with speed and quality.
  • Contributes to the quality improvement of the study processes and other procedures.
  • Ensures all systems are continuously updated.
  • Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
  • Provides direction to CRAs and CSAs on major study commitments including resolving any key issues identified.
  • Ensures that study activities at country level comply with local policies and code of ethics.
  • Reviews monitoring visit reports of direct reports in line with AZ SOPs
  • Reviews Accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans.
  • Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development. Ongoing communication with Functional Service Providers, including directions and feedback on insourced/outsourced work

Education

B.S., Bachelor of Science - Health And Fitness

East Carolina University
Greenville, NC
12.1994

Associate of Arts -

Brevard College
Brevard
08.1992

Skills

  • Shared filing platforms: SharePoint
  • Smart Sheet/ MS Project
  • BRIMS
  • EDC/ Medidata RAVE
  • Microsoft Office Suite
  • IRT/ IVRS Endpoint / 4G
  • Veeva: CTMS, Quality, eTMF
  • LMS (Learning Management System)
  • Project management
  • Strategic leadership
  • Analytical thinking
  • Coaching and mentoring
  • Relationship building
  • Decision-making
  • Team collaboration and leadership
  • Process improvement
  • Key relationship management
  • Operations management
  • Critical thinking
  • Key relationship development
  • Onboarding and training
  • Organizational development
  • Budget management
  • Budget development
  • Hiring and training
  • Work Planning and Prioritization
  • Program development
  • Resources allocation
  • Performance evaluations
  • Diversity and inclusion initiatives
  • Strategic planning
  • Stakeholder engagement
  • Regulatory compliance
  • Contract negotiation
  • Contract management
  • Risk analysis
  • Task delegation
  • Financial management

Therapeutic Areas of Experience PH I-IV

  • Infectious Disease, COVID II-III; Flu III; H1N1 III; RSV
  • Immuno-oncology, NSCL II-III; Small Cell II and III; Pancreatic
  • Central Nervous System (Anxiety, Bipolar, Schizophrenia- in patient) II, III and IV
  • Rare Disease (severe asthma) II and III
  • Cardiovascular (CABG) III; BP II-III
  • Post Transplant IV
  • Seasonal Allergy II-III
  • Women’s Health- PCOS, HRT II-III
  • Ophthalmology II-III and IV
  • Global experience in all regions

Timeline

Associate Director, Clinical Operations

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 Pharmaceutical
01.2019 - 03.2022

Associate of Arts -

Brevard College

B.S., Bachelor of Science - Health And Fitness

East Carolina University

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