Experience

Stoke Therapeutics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Clinical Data Manager

  • Jan 2022 - Present



X4 Pharmaceuticals

• Cambridge Massachusetts

• Administrative Assistant

  • Sep 2016 - Present

  Temporary administrative assistant responsible for general clerical duties to include but not limited to: photocopying, faxing, mail distribution and filing, creating SOP's. Coordinates and maintains records for staff office space, phones, company credit cards and office keys. Creates and modifies various documents using Microsoft Office. Temporary administrative assistant responsible for general clerical duties to include but not limited to: photocopying, faxing, mail distribution and filing, creating SOP's. Coordinates and maintains records for staff office space, phones, company credit cards and office keys. Creates and modifies various documents using Microsoft Office.



Deciphera Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Clinical Data Manager

  • May 2020 - Jan 2022

  • Assist in all the study specific CDM tasks • Forecast timelines and resources required to complete study-specific tasks on time and with high quality • Leads execution of CDM tasks according to the agreed upon timelines, mitigating risks as appropriate • Plans and facilitates internal and external study meetings • Assists in developing Data Management Plans and other CDM documents in collaboration with other functions • Collaborates with vendors and cross-functional teams to… Show more • Assist in all the study specific CDM tasks • Forecast timelines and resources required to complete study-specific tasks on time and with high quality • Leads execution of CDM tasks according to the agreed upon timelines, mitigating risks as appropriate • Plans and facilitates internal and external study meetings • Assists in developing Data Management Plans and other CDM documents in collaboration with other functions • Collaborates with vendors and cross-functional teams to develop Data Transfer Specifications • Reviews operational clinical study documentation including project timelines, meeting minutes, memos and study notes to file • Ensures that delegated and outsourced tasks are performed according to quality standards • May be required to review clinical protocols and provides input • Participate in eCRF design and Data Validation specifications • Ensures that study documentation is filed according to SOPs and Work Instructions; leads QC of study files for completeness and accuracy • Facilitates cross-functional data review for assigned studies • Generates and analyzes study metrics and informs cross-functional study teams • Assists in the development of eCRF Completion Guidelines Show less • Assist in all the study specific CDM tasks • Forecast timelines and resources required to complete study-specific tasks on time and with high quality • Leads execution of CDM tasks according to the agreed upon timelines, mitigating risks as appropriate • Plans and facilitates internal and external study meetings • Assists in developing Data Management Plans and other CDM documents in collaboration with other functions • Collaborates with vendors and cross-functional teams to… Show more • Assist in all the study specific CDM tasks • Forecast timelines and resources required to complete study-specific tasks on time and with high quality • Leads execution of CDM tasks according to the agreed upon timelines, mitigating risks as appropriate • Plans and facilitates internal and external study meetings • Assists in developing Data Management Plans and other CDM documents in collaboration with other functions • Collaborates with vendors and cross-functional teams to develop Data Transfer Specifications • Reviews operational clinical study documentation including project timelines, meeting minutes, memos and study notes to file • Ensures that delegated and outsourced tasks are performed according to quality standards • May be required to review clinical protocols and provides input • Participate in eCRF design and Data Validation specifications • Ensures that study documentation is filed according to SOPs and Work Instructions; leads QC of study files for completeness and accuracy • Facilitates cross-functional data review for assigned studies • Generates and analyzes study metrics and informs cross-functional study teams • Assists in the development of eCRF Completion Guidelines Show less



SDC (Statistics & Data Corporation)

• United States
• Biotechnology
• 100 - 200 Employee

• Clinical Data Manager

  • Feb 2020 - May 2020

  • Perform study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc. • Allocate and prioritize workloads for multiple projects (media control, data entry, pre entry review and query management tasks) • Serve as a primary or backup resource for issues pertaining to data management • Serve as an interim resource for issues pertaining to the study… Show more • Perform study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc. • Allocate and prioritize workloads for multiple projects (media control, data entry, pre entry review and query management tasks) • Serve as a primary or backup resource for issues pertaining to data management • Serve as an interim resource for issues pertaining to the study in the absence of the Project Clinical Data Manager • Assist other Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities • Mentor all levels of Clinical Data Analysts in their job responsibilities • Maintain quality control of the data, project deliverables and closeouts • Support and facilitate the review of medical coding for validity and completeness

• Sr. Clinical Data Associate

  • Dec 2019 - Feb 2020

  • Track and maintain audit-ready clinical study documentation within the electronic and/or hard copy Trial Master Files for multiple projects • Participate in database setup including programming specification document creation and review, data entry screen and validation check writing and testing, Case Report Form Completion Guidelines development, etc. • Perform data entry and query management including data listing review, query creation and resolution • Assist Clinical Data Manager… Show more • Track and maintain audit-ready clinical study documentation within the electronic and/or hard copy Trial Master Files for multiple projects • Participate in database setup including programming specification document creation and review, data entry screen and validation check writing and testing, Case Report Form Completion Guidelines development, etc. • Perform data entry and query management including data listing review, query creation and resolution • Assist Clinical Data Manager in allocating and prioritizing workloads for multiple projects, as needed • Serve as an interim resource for study issues pertaining to data management in the absence of the Clinical Data Manager • Assume Clinical Data Manager responsibilities for small studies • Mentor and train Clinical Data Analysts in query management and other CDA activities • Maintain quality control of the data, project deliverables and closeouts • Generate, send and track receipt of Training Forms for new database users; complete User Access Request Forms • Participate and/or lead internal and external team meetings, as necessary • Assume any tasks outlined in Clinical Data Analyst job description, as needed

• Clinical Data Associate

  • Apr 2018 - Dec 2019

  • Ensure highest data quality and integrity through clinical data management, including: o Protocol review, data management trial master file setup and maintenance, clinical database creation, edit check programming; o Import, integration and cleaning of electronic data (lab, ECG, PK, diary data, etc.); o Query reconciliation, including review, creation and resolution in iMedNet, Medidata Rave, Veeva, and DataTrak o Perform regular quality control of data • Ensure compliance with… Show more • Ensure highest data quality and integrity through clinical data management, including: o Protocol review, data management trial master file setup and maintenance, clinical database creation, edit check programming; o Import, integration and cleaning of electronic data (lab, ECG, PK, diary data, etc.); o Query reconciliation, including review, creation and resolution in iMedNet, Medidata Rave, Veeva, and DataTrak o Perform regular quality control of data • Ensure compliance with FDA’s CDISC standards • Create and maintain the following documents: Study Design Specifications (SDS), Data Validation Manual (DVM), Data Management Plan (DMP), eCRF Completion Guidelines (eCCG’s), Study Report Specifications (SRS) • Lead internal and external team meetings to ensure project deliverables and study closeouts remain on-track • Assist in review of medical coding for validity and completeness • Develop standard operating procedures (SOPs) and training documents, including training and interviewing of SDC new hires • Perform user acceptance testing (UAT) on eCRFs and data validation checks • Perform study start up tasks and study close out tasks



ECOG-ACRIN Cancer Research Group

• Greater Boston Area

• Clinical Data Associate

  • Jan 2017 - Apr 2018

   Review, evaluate and maintain data for 2 clinical trials or 278 patients of the E1a11 and E3108 enrollment, using Medidata Rave, and Oracle software.  Determination of patient eligibility, response, and treatment characteristics specific to E1a11 (Myeloma) and E3108 (Breast)  Collaborate with the Project Coordinator and other team members to remain current on best practices and protocol/policy implementations and amendments  Originate and respond to queries to ensure any… Show more  Review, evaluate and maintain data for 2 clinical trials or 278 patients of the E1a11 and E3108 enrollment, using Medidata Rave, and Oracle software.  Determination of patient eligibility, response, and treatment characteristics specific to E1a11 (Myeloma) and E3108 (Breast)  Collaborate with the Project Coordinator and other team members to remain current on best practices and protocol/policy implementations and amendments  Originate and respond to queries to ensure any discrepancies are resolved by using a Data Management Plan  Effectively communicate with Clinical Research Associates to ensure proper protocol execution Show less  Review, evaluate and maintain data for 2 clinical trials or 278 patients of the E1a11 and E3108 enrollment, using Medidata Rave, and Oracle software.  Determination of patient eligibility, response, and treatment characteristics specific to E1a11 (Myeloma) and E3108 (Breast)  Collaborate with the Project Coordinator and other team members to remain current on best practices and protocol/policy implementations and amendments  Originate and respond to queries to ensure any… Show more  Review, evaluate and maintain data for 2 clinical trials or 278 patients of the E1a11 and E3108 enrollment, using Medidata Rave, and Oracle software.  Determination of patient eligibility, response, and treatment characteristics specific to E1a11 (Myeloma) and E3108 (Breast)  Collaborate with the Project Coordinator and other team members to remain current on best practices and protocol/policy implementations and amendments  Originate and respond to queries to ensure any discrepancies are resolved by using a Data Management Plan  Effectively communicate with Clinical Research Associates to ensure proper protocol execution Show less



Alkermes

• Ireland
• Biotechnology Research
• 700 & Above Employee

• Sales Operations Intern

  • Jul 2016 - Sep 2016

  Summer intern responsible for ensuring accuracy of data content held in various software systems utilized by the sales team. Wrote SOPs on navigating through Medpro and the addition of prescribers and contacts into Veeva. Attended various lunch-n-learn educational seminars. Summer intern responsible for ensuring accuracy of data content held in various software systems utilized by the sales team. Wrote SOPs on navigating through Medpro and the addition of prescribers and contacts into Veeva. Attended various lunch-n-learn educational seminars.



Commercial Insurance Agency, Inc

• Belmont, MA

• Account Assistant

  • May 2016 - Jul 2016

  Summer intern responsible for educating clients of various insurance coverage options and ultimately assisting in the sale and renewal of automobile insurance. Performed data entry and provided superior quality customer service to clients. Summer intern responsible for educating clients of various insurance coverage options and ultimately assisting in the sale and renewal of automobile insurance. Performed data entry and provided superior quality customer service to clients.