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Job Description Summary
The Principal Data Manager leads and drives the DM team, acting as mentor and coach and as the reference point for the Sponsor and the appointed person responsible for the project from the Data Management perspective, to develop the data collection specification from all data sourcesThe Principal Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, ensures DM tasks for the assigned studies are performed on time and within budget, makes recommendation for process improvement and/or new standards development.
The Principal Data Manager is an effective input into strategic planning across the department and bridges scientific or medical knowledge to data management processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets.
Job Description
KEY RESPONSABILITIES
- Accountable for driving achievement 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 study team
- Define and executive 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 proritising
- Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level
- Proven ability to analyse data capture problems/opportunities and a track record of developing and delivering high quality solutions
- Demonstrate broad and integrated knowledge of all aspects of Data Management providing consultancy to other groups outside CDM
- Educate/train on use of study specific data collection tool(s) and query management process
- Effectively contribute in formal training for new starters
- Make recommendations for process improvements and development of new standards
- Maintain continuous and appropriate communication with sponsors and share with them critical and general issues
- Effective relationship management with vendors and customers in order to meet expectations and achieve results
- Effectively represents Data Management in internal or external meetings (e.g. Investigator’s Meetings)
- Perform CRO oversight
- Any other activities as needed
DESIRED QUALIFICATION & EXPERIENCE
- Degree in life science, pharmaceutical, biology or related field or at least 6 years’ experience in data management field or similar in a pharmaceutical environment or equivalent
- Knowledge of Data Management processes, Very Good
- Knowledge of pharmaceutical industry guidelines like ICH, GCP etc, Very Good
- Expert in one or more DM systems or processes and recognized for their expertise
- Able to propose standards across studies and therapeutic areas
TECHNICAL COMPETENCES & SOFT SKILLS
- English, Good
- MS Office Suite, Good
- 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
- Analytical thinking
- Resilient
- Ability to Influence and motivate
- Ability to manage difficult conversations
- Innovative
- Ability to Provide Constructive Feedback
- Excellent Presentation Skills
- Commercial awareness
- Ability to recognize and develop talent
Languages
English
Education
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacology
Contract Type
Regular
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