Manager Clinical Data Management

• May 2019 - Present

Trial Data Manager

• Jun 2017 - May 2019

Clinical Data Manager

• Feb 2016 - Jun 2017

Data Management Project Lead

• Nov 2014 - Nov 2015

Responsible for the planning, management and execution of all Data Management related activities for two Phase I Oncology studies using an EDC system. • Serve as Data Management Lead on selected studies • Create study specific Data Management Plans (DMPs) • Provide input and assistance in the production of Case Report Forms (CRFs) design • Assist and oversee in preparation of data entry guidelines for specific studies • Assist and oversee in the creation of test data for entry screens and edit checks • Oversee test data entry screens as per data entry guidelines and CRF for specific project work • Create, issue and update the database with resolved data queries • Review project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes • Serve as primary contact for DM with Clinical Operations or Sponsor • Work concurrently on multiple projects • Escalate and follow-up on project issues as appropriate • Ensure that all study team members are aware of their requirements according to the agreed budget • Inform management if there is a requirement to deviate from agreed budget, timelines or resources or of potential Out Of Scope activities • Assemble files and ensure documents for the trial master file to accurately reflect the progress of the study • Liaise with all other appropriate departments within Chiltern International to ensure smooth running of the study • Assist with mentoring of CDAs within the department • Perform all tasks to relevant Chiltern or Client Company SOPs, ICH or other regulatory guidelines in DM • Work in a timely manner in accordance with all the activities specified in the agreed study budget • Attend and present at Investigator meetings as required Show less

Senior Clinical Data Manager

• Apr 2008 - Sep 2014

Responsible for planning, managing and performing all Data Management activities in all three main phases of a Clinical trial (start up, conduct/maintenance and close-out) in accordance with SOPs, WIs, Protocol and study specific guidelines. Duties included: • Performing study start up activities, including designing eCRFs, creating test data and User Acceptance Testing. • Management of all clinical trial data, including external data (e.g. Lab, PK, ECG data). • Drafting and maintaining key Clinical trial documentation e.g. DMP, eCRF completion guidelines, CRFs, project plans, training presentations. • Assist with SAE reconciliation and Coding. • Attend study meetings and provide updates, communicate data issues and/or query trends to functional area colleagues (Biostatistics, Safety etc.) • Interact with other functional area colleagues, including, but not limited to: Biostatistics, Clinical Programming, Clinical Operations, Safety and Medical Coding. • Prepare and provide training to site monitors, site personnel and Investigators on eCRF completion. • Supervision and management of FSP Data Management resource. • Organized, coordinated and prepared training materials for Monitor workshops and Investigator meetings. Show less

Lead Data Manager

• Dec 2006 - Dec 2007

Worked on an International, multi-site, Rheumatoid Arthritis study using Oracle Clinical in conjunction with EDC (Macro). I was responsible for reviewing and cleaning clinical trial data from 8 country sites. Worked on an International, multi-site, Rheumatoid Arthritis study using Oracle Clinical in conjunction with EDC (Macro). I was responsible for reviewing and cleaning clinical trial data from 8 country sites.

Clinical Data Manager

• Feb 2005 - Nov 2006

Worked as a Lead Data Manager on a 700 patient Osteoarthritis study, under the supervision of a Trial Data Manager, using in-house EDC system. 1. Review and clean clinical trial data, including generating and resolving queries. 2. Generating protocol violator reports and entering Protocol Violators into clinical database. 3. Perform External Data reconciliation. 4. Act as a point of contact for the study and deal with all queries and issues raised by other Novartis staff e.g. CRA’s and Site Monitors 5. Represent Novartis CDM when attending teleconferences and study meetings. Show less