Lead Data management activities and ensure study deliverables meet timelines and quality standards.
Review of Clinical research documents (e.g. protocols, Case Report Forms).
Create and review electronic Case Report Form (eCRF) specifications.
Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
Develop edit rules/checks, query logic and query messages.
Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
Create and provide training to the clinical team and sites.
Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
Coordinate the archiving of study databases and related documents
Create Data Transfer Specifications and perform external vendor reconciliation.
Perform SAE reconciliation.
Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.

Requirements

Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or related field or nursing degree.
Atleast 3 years data management and/or related work experience in a pharmaceutical industry.
Working knowledge of Clinical research and clinical trial process and related regulatory requirement and terminology.
Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave, Oracle InForm, OpenClinica and Medrio.
Perform duties in compliance with SOPs, GCP and ICH guidelines.
Ability to prioritize and to adapt quickly in fast-paced and changing industry conditions.
Ability to lead a study or data management team independently.
Proactively drive quality and efficiently to meet timelines and milestones to deliver high quality data management deliverables.
Excellent verbal and written communication skills.
Proficient in the use of Microsoft office(Outlook, word, excel, powerpoint, etc)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data managementelectronic Case Report Form (eCRF) specificationsData Management PlanData Validation PlanUser Acceptance Testing Planedit rules/checksquery logicSAE reconciliationdata review/reconciliationdatabase lock/unlock

Soft Skills

leadershipcommunicationadaptabilityprioritizationquality assuranceteam managementclient satisfactionproactive problem solvingtime managementtraining

Certifications

Bachelor’s degree in clinical sciencesBachelor’s degree in pharmacyBachelor’s degree in biological sciencesBachelor’s degree in mathematical sciencesnursing degree