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Data Manager/Senior Data Manager

4 weeks ago

Boston MA, United States Alira Health Full time

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
The Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical and statistics to develop the data collection specification from all data sources
The Senior Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, leads and drive the DM team, and acts as the reference point for the Sponsor and the appointed person responsible for the project from the data management perspective.
Job Description
Provide Data Management input into the protocol
Design the Case Record Form and guide process for CRF approval
Define and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study team
Validation of the database and computerized checks, including SAS listings or SAS checks
For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF
For EDC studies timely response to issues identified by the eCRF Helpdesk
Prepare CRF completion guidelines
Prepare study specific data-entry guidelines and train data-entry staff
Perform term coding for clinical studies, raise manual queries for uncoded terms as required
Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings
Create and test import programs for electronic data received from external vendors
Perform timely data integration of CRF and non CRF data (data import from external sources)
Perform reconciliation of external data (e.g. SAE, Central Labs, ECGs, etc)
Run and monitor study data progress reports including query management and take appropriate actions (e.g. escalation, re-training, etc), escalate any study issues within study team
Define and execute QC plan, lead and execute database release and database freeze activities
Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing
Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level
Effectively contribute in formal training for new starters
Demonstrate good application of document management process and procedures
Follow SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc to day-to-day activities
Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing; monitor progress of activities
Maintain continuous and appropriate communication with sponsor and share with them critical and general issues
Effectively represents Data Management in internal or external meetings (e.g. Investigator's Meetings)
Conduct other activities as required

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
Degree in life science, pharmaceutical, biology or related field or at least 3 years' experience in data management field or similar in a pharmaceutical environment or equivalent
Knowledge of Data Management processes, Good
Knowledge of pharmaceutical industry guidelines like ICH, GCP etc, Good
Knowledge of coding dictionaries like MedDRA and WHO-DD or equivalent, Good
Knowledge in one or more DM systems, Good
English, Good
MS Office Suite, Good

Languages
English
Education
Contract Type
Regular
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