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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 delivers a quality database in accordance with the project plan, leads and drives 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.
ROLEThe 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 delivers a quality database in accordance with the project plan, leads and drives 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.
KEY RESPONSABILITIESAccountable for driving achievements of project milestones from study start-up through to delivery of database.
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 the 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.
Make recommendations for process improvements and development of new standards.
Develop and maintain a network of contacts within the study team.
Maintain continuous and appropriate communication with sponsor and share with them critical and general issues.
Effectively represent Data Management in internal or external meetings (e.g. Investigator's Meetings).
Conduct other activities as required.
DESIRED QUALIFICATION & EXPERIENCEDegree 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.
Knowledge of pharmaceutical industry guidelines like ICH, GCP etc.
Knowledge of coding dictionaries like MedDRA and WHO-DD or equivalent.
Knowledge in one or more DM systems.
TECHNICAL COMPETENCES & SOFT SKILLSEnglish.
MS Office Suite.
Professional.
Trustworthy.
Ability to effectively prioritize.
Quality focused.
Personable Attitude.
Willingness to learn.
Team Player.
Effective Stress Management Techniques.
Learning Agility.
Ability to Manage Conflict.
Problem Solving Skills.
Effective Verbal Communication Skills.
Commercial and Technical Writing Skills.
Networking Skills.
Languages English
Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy
Contract Type Regular
Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.
Why Work at Alira Health?With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.
Join Our TeamWe are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.
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