PORCHYA M. MCCOLLUM
Pennsauken,NJ
Summary
Experienced Clinical Research Professional with Project Management experience and 31 years experience in the industry and 26 years experience in Data Management specifically. Advanced Manager that will lead, track, plan, and deliver end to end Data Management (Database set-up to Database Close) with quality within timelines, Vendor Management, Lab and SAE Reconciliation. In addition, very experienced in writing study review plans, SOP's and Work instructions(experience in training on plans, work instructions, plans) experience in FSP model trials.
Overview
30
30
years of professional experience
Work History
Data Analyst (Contract Position)
World Gennus
01.2025 - 07.2025
- Utilized Microsoft Excel to generate reports and graphs based on complex datasets.
- Analyzed data trends and created visualizations for management review.
- Created SQL queries to extract data from multiple sources for reporting purposes.
- Collaborated with other departments to ensure data accuracy and integrity.
- Reviewed large amounts of data across multiple platforms and sources to determine operational impacts and needed actions.
- Evaluated large datasets to identify trends and develop actionable insights.
- Designed and developed dashboards with Tableau to visualize complex business metrics.
- Leveraged statistical methods to analyze data.
- Used automated reports to help stakeholders understand complex data.
Senior Data Manager Lead (Remote)
Bristol Myers Squibb
08.2021 - 01.2025
- Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
- Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
- Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members
- Performed oversight of various Clinical Trials and Vendor Management
- Performed CRO Management
- Provides strong quality and project oversight over third party vendor responsible for data management deliverables
- Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway)
- Enforces data standard conventions and quality expectations for clinical data per defined processes
- Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
- Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness
- Represents DM on cross-functional project teams & submission Teams
- Lead or support the Health Authority inspections and audits
- Provides coaching and quality oversight of junior Data Management Leads core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
- Defining the roadmap and implementation of innovative solutions
- Ensure oversight and governance of CDM deliverables with specific focus on high value clinical trials
- Deliver consistently on functional performance metrics of CDM operations
- Leading a global team of CDM professionals
- Focus on engagement and retention of staff to maximize their potential
- Empowering and holding CDM staff accountable for high quality performance
- Engage and energize employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities
- Author and update SOPs
Project Manager, Data Manager (Remote)
PAREXEL
04.2019 - 08.2021
- Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications
- Ensure the project/program is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill regulations (including oversight and maintenance of relevant data operations project documentation)
- Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave)
- Thorough knowledge of electronic source data capture systems (e.g CLIN Base)
- Managed Clinical Trials from Study Start -up to Database Lock and oversight of Vendors
- Thorough knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system (MyTrials, IVRS etc.) and Reporting functionality within the EDC system
- Thorough knowledge of all DB set-up activities including but not limited to Database Configuration Specifications, Data Validation
- Thorough knowledge of all activities during Study Maintenance and Database Lock
- Review of metrics to determine risks and risk migration plans as required
- Effectively communicate to and manage internal project teams, external customers and third-party vendors
- Hold team meetings on a regular basis
- Participate in client, investigator and team meetings
- Effectively manage contracted project delivery
- Highlight issues/risks to delivery and mitigate risks for both PAREXEL and the client
- Manage appropriate project level resourcing of staff and staff assignments
- Ensure information entered management systems is accurate and updated on a regular basis
- Participate in cross functional meetings and drive initiatives, participate in Business Development and BID Defense meetings as required
- Prepare, participate in and follow up on audits/inspections
- Conduct Internal audits
- Participate in meeting with Business Development /PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client Collaboration with the Clinical team to review the CLIN Base setup performed by the pharmacy, safety Laboratory team and Clinical Database Designer
Project Data Manager (Remote)
Duke Clinical Research Institute
05.2016 - 04.2019
- Manage Clinical data from study start up through database lock utilizing the iMedidata, Medrio EDC systems
- Participate in bid defense meeting
- Author SOPs and WIs
- Design the database for data collection
- Monitor and track the data collection process; review patient data entered in the central database; ensure deliverables meet the requirements of time and quality; conduct validity checks for each study based on protocol specifics
- Assign tasks and responsibilities within Data Management to team members
- Assess ongoing and future resource needs of the project
- Trouble shoot data collection/management process deficiencies; determine appropriate course of action for resolving data errors
- Oversee Data Management Plans, Completion Guidelines, Edit check Specifications
- Resolve all issues within Data Management project
- Oversee and forecast budgets
- Manage Vendors
- Oversee Data Quality Management Plan
- Oversee coding for projects (MedDRA, WHO Drug)
Clinical Data Manager
ICON Clinical Research
04.2010 - 03.2016
- Protocol review and approval, manage study team, Manage Clinical data from study start up through database lock
- Monitor and track the data collection process; review patient data entered in the central database; coordinate with vendors and study managers to ensure deliverables meet the requirements of time and quality
- Conduct validity checks for each study based on protocol specifics; trouble shoot data collection/management process deficiencies; determine appropriate course of action for resolving data errors
- Write Data Management Plan, Completion Guidelines, and Edit checks
- Conduct UAT Testing
- Track validation discrepancies through collaboration with clinical study managers; issue manual queries for data errors wherever applicable
- Close out un-resolvable queries; document all activities related to database maintenance
- Manage the entire process of data collection and transfer during ongoing phase of the study
- Prepare database lock at the end of the trial; develop and maintain study-specific Data Management Plans
- Managed external vendors and responsible for Lab and SAE reconciliation
Clinical Data Coordinator III
ICON Clinical Research
07.2009 - 04.2010
- Monitor and track the data collection process; review patient data entered in the central database; coordinate with vendors and study managers to ensure deliverables meet the requirements of time and quality
- Manage protocol, assist in the design case report forms
- Manage clinical data from study start up through database lock
- Conduct validity checks for each study based on protocol specifics; trouble shoot data collection/management process deficiencies; determine appropriate course of action for resolving data errors; track validation discrepancies through collaboration with clinical study managers; issue manual queries for data errors wherever applicable; close out un-resolvable queries
- Database maintenance; manage the entire process of data collection and transfer during ongoing phase of the study; prepare database lock at the end of the trial; develop and maintain study-specific Data Management Plans, Data Review guidelines, and Study Completion Guidelines
Senior Clinical Data Coordinator II
ICON Clinical Research
07.2001 - 07.2009
- Responsible for writing edit check specifications, validation of edit checks, writing study specific procedures, liaison for India staff
- CRF design, communicate with sponsors and clinical medical team on various issues
- Track study progress, assist in database lock, assisted in writing and review of programmed edit checks and manual review of the CRF, and writing SSP conventions
- Communicate ongoing trends to the sponsor through a written report, performed data and listing review audits
- Utilized Oracle Clinical system, ClinTrials
- Guide investigators on HRPP processes and submission documentation
- Review human subject protocol submissions and determines document completion for submission requirements and review processes
Clinical Data Coordinator
Fox Chase Cancer Center
05.1999 - 07.2001
- Interviewing, screening and providing detailed information about phase I -4 Cancer Clinical Trials at or in conjunction with Fox Chase Cancer Center (Community Clinical Centers)
- Provided information and referrals for clinical trials various types (ex: Breast, lung, stomach etc.)
- Assisted in pre-initiation visit of breast cancer Trials Provided Information on Informed consent and Clinical Trials as treatment options and the various phases of clinical trials
- Manual review of case reports forms using datafax
- Web based CRF design
Clinical Research Coordinator
Athan Allergy & Associates
04.1997 - 05.1999
- Responsible for ordering supplies and reporting and documenting misplaced supplies
- Compile and maintain internal study file for completeness and compliance with FDA regulations
- Resolved data queries, and AE, SAE transmission and collection
- Full-time position
- Created tools that aid in protocol adherence, coordinated study Documentation such as clinical study agreement; master’s service agreement and work order for initiating clinical studies
Project research Associate
IBRD-Rostrum Global
06.1995 - 04.1997
- Created tools that aid in protocol adherence, Coordinated study Documentation such as clinical study agreement, master’s service agreement and work order for initiating clinical studies
- Responsible for ordering supplies and reporting and documenting misplaced supplies
- Compile and maintain internal study file for completeness and compliance with FDA regulations
- Resolved data queries, and AE, SAE transmission and collection
Education
Bachelor of Science - Biology/ Health-Science
Lincoln University
Lincoln University, PA05-1994
Skills
- End to End Clinical Data Management
- Project Management and Leadership skills
- Vendor Oversight
- Data Reconciliation
- Quality Deliverables
- Complex issues resolves
- Experience in multiple EDC systems
- Experience in multiple Therapeutic areas (Oncology, Hematology, Lung, Obesity, COVID, Registry, Respiratory, Neurological, Observational, Medical Device
Timeline
Data Analyst (Contract Position)
World Gennus
01.2025 - 07.2025
Senior Data Manager Lead (Remote)
Bristol Myers Squibb
08.2021 - 01.2025
Project Manager, Data Manager (Remote)
PAREXEL
04.2019 - 08.2021
Project Data Manager (Remote)
Duke Clinical Research Institute
05.2016 - 04.2019
Clinical Data Manager
ICON Clinical Research
04.2010 - 03.2016
Clinical Data Coordinator III
ICON Clinical Research
07.2009 - 04.2010
Senior Clinical Data Coordinator II
ICON Clinical Research
07.2001 - 07.2009
Clinical Data Coordinator
Fox Chase Cancer Center
05.1999 - 07.2001
Clinical Research Coordinator
Athan Allergy & Associates
04.1997 - 05.1999
Project research Associate
IBRD-Rostrum Global
06.1995 - 04.1997
Bachelor of Science - Biology/ Health-Science
Lincoln University