Principal, Data Manager - Alira Health
Boston, MA 02108
About the Job
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 SummaryThe Principal 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 sourcesThe 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 DescriptionROLEThe 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 sources The 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.KEY RESPONSABILITIESAccountable for driving achievement of project milestones from study start up through to delivery of databaseProvide Data Management input into the protocolDesign the Case Record Form and guide process for CRF approvalDefine and develop the Data Management Plan, Data Validation Plan and their annexes (e.g.
Reconciliation Plan), with input from the study teamValidation 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 issuesEffective 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) Conducts other activities as required DESIRED QUALIFICATION & EXPERIENCEDegree 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 Proficiency in Medidata Rave or Merative ZeltaOncology experienceTECHNICAL COMPETENCES & SOFT SKILLS English, Very GoodMS Office Suite, GoodProfessional 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 SkillsCommercial 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 LanguagesEnglishEducationBachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacologyContract TypeContingency WorkforceSummaryLocation: Europe-Remote; Boston-RemoteType: Full time
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 SummaryThe Principal 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 sourcesThe 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 DescriptionROLEThe 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 sources The 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.KEY RESPONSABILITIESAccountable for driving achievement of project milestones from study start up through to delivery of databaseProvide Data Management input into the protocolDesign the Case Record Form and guide process for CRF approvalDefine and develop the Data Management Plan, Data Validation Plan and their annexes (e.g.
Reconciliation Plan), with input from the study teamValidation 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 issuesEffective 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) Conducts other activities as required DESIRED QUALIFICATION & EXPERIENCEDegree 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 Proficiency in Medidata Rave or Merative ZeltaOncology experienceTECHNICAL COMPETENCES & SOFT SKILLS English, Very GoodMS Office Suite, GoodProfessional 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 SkillsCommercial 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 LanguagesEnglishEducationBachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacologyContract TypeContingency WorkforceSummaryLocation: Europe-Remote; Boston-RemoteType: Full time
Source : Alira Health