Colleen Cox Email and Phone Number
Colleen Cox's Location
Natick, Massachusetts, United States, United States
Colleen Cox's Contact Details
Colleen Cox work email
- Valid
- Valid
- Valid
- Valid
Colleen Cox personal email
n/a
Colleen Cox phone numbers
About Colleen Cox
Colleen Cox is a Experienced Clinical Data Management Professional at Editas Medicine. She possess expertise in clinical data management, data management, clinical trials, pharmaceutical industry, clinical research and 21 more skills.
Colleen Cox's Current Company Details
Colleen Cox Work Experience Details
-
Senior Director, Clinical Data ManagementEditas Medicine Jun 2024 - PresentCambridge, Massachusetts, Us
-
VolunteerSociety For Clinical Data Management 2000 - PresentBrussels, Brussels, Be -
Director, Clinical Data ManagementMersana Therapeutics Apr 2021 - May 2024Cambridge, Ma, Us -
Director, Data Analytics And ManagementIntellia Therapeutics, Inc. Oct 2019 - Apr 2021Cambridge, Massachusetts, Us -
Director, Clinical Data ManagementAkebia Therapeutics Sep 2018 - Oct 2019Cambridge, Ma, Us -
Associate Director, Clinical Data ManagementAkebia Therapeutics Mar 2018 - Sep 2018Cambridge, Ma, Us
-
Manager, Data ManagementAlkermes Aug 2016 - Mar 2018Dublin, Ie -
Principal AnalystBiogen Jul 2014 - Aug 2016Cambridge, Ma, UsResponsible to develop a standard set of KPIs to measure partner performance. Continuously analyzes partner KPIs and summarizes performance to DM Management Team. Monitors implementation of resolutions and ensures improvement via further KPI results.Provides metrics development and analysis support to DM and other teams and departments within Development Sciences. Represents DM in relevant KPI and Metrics related cross-functional capability and operations initiatives.Develops strategy to analyze and monitor effectiveness of DM standard CRFs, discrepancies, and processes. Monitors quality of standards, the extent to which they work as expected, and pain points related to their implementation. Example: Analyze percent of edit checks that result in a change to the database. Analyzes data and presents suggestions for improvements to standards team and DM quality team.Oversees and facilitates consistent targeted lessons learned meetings. Summarizes and trends outcomes and issues. Categorizes results and works with DM quality team and other affected functions to implement necessary process improvements and training. Implements processes to gather regular and detailed feedback on partner performance from both internal and partner Data Management staff. Categorizes results and presents to DM leadership team. Provides analysis of issues and works with relevant DM staff to implement project and departmental level solutions and training. Represents DM at industry metrics conferences/meetings. Participates in industry events and forums. Leverages expertise of current industry trends and best practices within DM as relevant. -
Senior Manager, Data ManagementInfinity Pharmaceuticals Dec 2011 - Jul 2014Cambridge, Massachusetts, Us -
Manager, Data ManagementOutcome May 2011 - Dec 2011Cambridge, Ma, Us -
Senior Clinical Data ManagerTolerrx, Inc. Mar 2009 - Apr 2011UsManaged the vendors who provided data and/or data management services including the revision and maintenance of the issue resolution process and metric management. Coordinated the review of data across multiple trials with the medical monitors and followed findings through to resolution. Documented, implemented departmental and/or team decisions including follow through to ensure understanding by the vendor and completion of the necessary actions; including assisting with the creation and maintenance of data management documentation. Assisted in the coordination, generation and collation of trial data for regulatory authority review and for supporting marketing applications globally. Worked with Clinical Operations, involved in study setup and management-related activities including protocol review, CRF/eCRF Design, study set-up activities, clinical data review, quality control of data, reviewing/writing all study guidelines, documented procedures as required at both the study and the program level. In the corporate environment, involved with activities relating to identification of data sources (ePRO), data structure analysis and documentation. Balanced 7 to 10 projects within the TRX4 program while maintaining solid documentation in compliance with both international regulatory requirements and Tolerx corporate expectations. Represented Data Management in clinical and corporate project team interactions on the development of the Serious Adverse Event Reconciliation process and the coding (both medications and medical conditions) processes. Coordinated work among team members and with other functional units, both internal and external. Developed standard operating procedures relating to data structures and management, using CDISC and CDASH standards as guidelines. Trained team members, both within and outside of Data Management, as appropriate on both processes and study specific therapeutic areas. -
Manager, Data ManagementPrometrika, Llc Feb 2005 - Mar 2009Responsible for the management of 4-16 staff ranging from data entry specialists to principal data managers and day to day operations of clinical trials for multiple sponsors and projects in multiple phases. Project manager for company's largest client managing multiple trials, varying from phase I to III including: resource assignment, out of scope determinations and all sponsor communications. Provide technical support when needed on other department projects. Work with project teams to determine priorities both within and across various trials. Coordinate or perform overall and study specific training, ensuring completion of both training and feedback. Develop, review and comment on study proposals, budgets and change in scope assessments and assist with departmental and company proposal template. Maintain existing standard operating procedures as well as incorporation of new SOPs for the department and assist in the review of those for other departments. Ongoing review of regulatory and industry updates to ensure ongoing compliance.Averion
-
Associate Manager, TrainingAverion May 2004 - Feb 2005Develops and conducts training program for Clinical Data Management staff. Develops and conducts cross-training in data management tasks for personnel and clients outside of the department. Provides one-on-one training to Clinical Data Management staff as needed. Coordinates training program with other functional departments. Serves as a resource to other Clinical Data Services staff and/or personnel and clients outside of the department. Performs general clinical data management support as needed including: reviewing data; assisting in database design and testing; designing CRFs and guidelines; designing and testing logic checks; querying investigators for missing or discrepant data; utilizing tools/systems to code medical terms and medications; interfacing with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management.
-
Manager, Data ManagementCarestat, Inc Dec 2001 - May 2004Responsible for the management of 20 personnel ranging from data entry specialist to senior data managers. Develop, review and comment on study proposals, budgets and change in scope assessments and assist with departmental and company proposal template. Develop, maintain and implement standard operating procedures for the department and assist in the development of those for other departments and coordinate or provide appropriate training. In conjunction with the IT department, definition of system requirements for both a clinical data management system and an autoencoder; oversee and/or participate in the validation of the systems. Write and maintain training materials for in-house systems and processes. Performed training and ensured completion of both training and feedback. Working with project teams to determine priorities both within and across various trials. Technical support when needed on projects. Ongoing review of regulatory and industry updates to ensure ongoing compliance.
-
Manager, Data ManagementHarvard Clinical Research Institute Jun 2001 - Dec 2001Responsible for the management of 12 personnel ranging from associate to senior data managers. Oversee the day to day operation of the department including the interaction with other departments within HCRI. Responsible for the review and approval of data management sections of study budgets, including assisting in the development of the proposal process including budgetary line items and proposal wording. Reviewed and updated standard operating procedures (SOPs) for existing data management system; created and implemented SOPs for the integration of the ClinTrial clinical data management system. Ongoing assessment of both standard and study specific workflows to enhance procedures, processes and efficiencies. Data management representative during sales presentations and sponsor audits. Development of training plan for training staff including both the integration of in-house experts and the appropriate regulatory guidelines.
-
Manager, Data Management System DevelopmentMedical And Technical Research Associates, Inc Aug 2000 - May 2001Responsible for the development, maintenance, installation and ongoing validation for all in-house data management systems. Data management systems include: image, web and facsimile based data management, autoencoder including a MedDRA component as well as a serious adverse event tracking and reconciliation system. Responsible for marketing and sales support of both data management systems and service. Definition and revision work-flows for both the system and study databases. System validation including multiple site location validation, system upgrade and modification validation. Prioritize and track system enhancements; coordination and support of in-house user group. Training of technology and system users. Develop and update appropriate SOPs, Work Instructions and Forms as needed.
-
Principal Data ManagerAai Development Services, Formerly Mtra Sep 1999 - Aug 2000Responsible for sales support, defining workflows, system validation, site location validation, system upgrade and modification validation. Prioritize and track system enhancements. Training of technology and system users. Develop and update appropriate SOPs, Work Instructions and Forms as needed. Continuation of responsibilities
-
Senior Data ManagerAai Development Services, Formerly Mtra Jul 1998 - Sep 1999Coordinate all Data Management tasks for a project using the Data Management Operational Plan (DMOP) as the primary communication tool. Develop DMOP, including database, logic/consistency and protocol compliance check specifications. Design CRFs using JetForm. Develop databases and validation checks using Access and Visual Basic. Manipulate and integrate electronic data from outside vendors. Generate, review and resolve edits. Primary contact for sponsor and other operational division leaders. Set timelines and personnel requirements for project team. Forecast project budgets and oversee compliance. Provide team with information and guidelines for completing project. Assist in training Data Managers.
-
Data AnalystAai Development Services, Formerly Mtra Jan 1998 - Jul 1998Review and code clinical CRFs, generate/resolve edits, design CRFs and program SAS datasets. Review Data Listings and Batch Edits Checks. Develop data management operational plans, including database, logic and consistency, and protocol compliance check specifications. Programming and testing of data listings and batch edit checks. Interface with medical staff, statisticians, programmers and pharmaceutical clients. Coordinate day to day operation of projects. Integral part of project team and project team meetings.
-
Clinical Data Systems ManagerUromed Corporation Aug 1997 - Jan 1998Interaction with both the statistician and study investigators to present study results in both presentation and abstract format. Received and incorporated study trial results from acquired technologies, including the creation of necessary analysis files and review of the pertinent study documentation. Responsible for the development and auditing of the standard operating procedures (SOPs) for the data management area. Continuation of the responsibilities of clinical data supervisor.
-
Clinical Data SupervisorUromed Oct 1995 - Aug 1997Suwanee, Ga, UsResponsibilities include review of protocols to provide data management and analysis input. Development of case report forms (CRFs) to facilitate ease of use by the clinical site, data processing and data analysis. Establishment of CRF tracking procedures, including the design, implementation and maintenance of tracking database to provide immediate, accurate assessment of CRFs in-house. Establish and maintain the ongoing data clarification form (DCF) database, including the integration of the use of NCR paper to eliminate needless photocopying as well as the generation of summary reports of types and counts of frequent errors; review of summary reports and communication with the sites to ensure the resolution of the above. Supervised the development of the data entry guidelines, including the definition of entry codes to facilitate data entry. Oversee data entry and verification to ensure constant availability of study data as well as continually updating of study timelines. Creation of export reports and programs, including the necessary validation to create SAS analysis files for use by the consulting statistician; when needed, conversion of the datasets from Macintosh to PC format. After review of the protocol, writing of the data validation guidelines for the study, which detail the acceptable responses for the data points collected based on the protocol and CRF requirements. Coding of the data validation programs in SAS to generate listings of outliers to be reviewed and if necessary, generate the appropriate DCF. -
Database Manager/Sas ProgrammerMuro Pharmaceutical, Inc Mar 1994 - Sep 1995Responsibilities included the review and critique of clinical protocols with regard to data collection procedures and data handling issues. Input in the design of CRFs, helping to standardize modules for future use. Determination of data checking requirements for protocols, working closely with the clinical research associates and clinical data managers. Working in conjunction with the biostatistician to develop file layouts for clinical databases. Development of databases to promote efficient entry, verification and facilitate the consolidation of data for CANDAs. Interaction with vendors as a technical consultant of the clinical data management as well as overall vendor qualification. Involvement in the design of the data structure for the Integrated Safety/Efficacy Summary as well as the corresponding CANDA datasets. Creation and maintenance of electronic coding dictionaries for both adverse events and concomitant medication. Development and support of in-house CRF tracking, both manual and automated.
-
Database ManagerParexel International Corporation Sep 1993 - Mar 1994Responsibilities included the design, support and maintenance of more complex, relational databases to ensure ease and clarity of entry. Monitoring of data entry and verification activity. Determination and programming of data quality checks to ensure quality and accuracy of trial data. Designing of custom reports and/or listings as designed by clients or other departments. Development of standardization to ensure consistency and efficiency across multiple datasets and databases. Conversion and incorporation of electronically transmitted data.
-
Database AssociateParexel Sep 1992 - Sep 1993Durham, North Carolina, UsDuties included the design, support and maintenance of databases to ensure the efficiency of data entry. Monitoring of data entry and verification activities as well as generation of the necessary data listings. Determination of, and programming of data checks to ensure consistency and accuracy of trial data. Designing of custom reports and/or listings as designed by clients or other departments. Development of standardizations to ensure consistency and efficiency across multiple datasets and databases. Conversion and incorporation of electronically transmitted data. -
Senior Data Support SpecialistParexel Dec 1991 - Sep 1992Durham, North Carolina, UsContinuation of responsibilities of a Data Support Specialist, now involving the division's largest and/or most complex projects. Reference on all aspects of position: medical terminology, computer hardware and software problems, as well as general and operating policies. Representation of Data Support Department at interdivisional and client technical meetings.
-
Data Support SpecialistParexel Dec 1989 - Dec 1991Durham, North Carolina, UsResponsibilities included design of case report forms in compliance with the protocol and the input of both clinical and database managers. Entry of information in compliance with an 0.5% error rate. Verification of case reports so that all information is consistent and correct.
Colleen Cox Skills
Clinical Data Management
Data Management
Clinical Trials
Pharmaceutical Industry
Clinical Research
Cro
Gcp
Software Documentation
Cdisc
Sop
Clinical Development
Edc
Validation
Sas
Data Analysis
Protocol
Good Clinical Practice
Fda
Clinical Monitoring
Standard Operating Procedure
Cro Management
21 Cfr Part 11
Regulatory Affairs
Documentation
Electronic Data Capture
U.s. Food And Drug Administration
Colleen Cox Education Details
-
Framingham State UniversitySpanish
Frequently Asked Questions about Colleen Cox
What company does Colleen Cox work for?
Colleen Cox works for Editas Medicine
What is Colleen Cox's role at the current company?
Colleen Cox's current role is Experienced Clinical Data Management Professional.
What is Colleen Cox's email address?
Colleen Cox's email address is cc****@****bia.com
What is Colleen Cox's direct phone number?
Colleen Cox's direct phone number is +161786*****
What schools did Colleen Cox attend?
Colleen Cox attended Framingham State University.
What skills is Colleen Cox known for?
Colleen Cox has skills like Clinical Data Management, Data Management, Clinical Trials, Pharmaceutical Industry, Clinical Research, Cro, Gcp, Software Documentation, Cdisc, Sop, Clinical Development, Edc.
Free Chrome Extension
Find emails, phones & company data instantly
Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Aero Online
Your AI prospecting assistant
Select data to include:
Total price:
$0.00
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial