27 days ago on jobs.celgene.com

Senior Data Manager

Celgene Switzerland SA

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Senior Data Manager

Senior Data Manager

Req #:16001736
Job Category:Clinical Operations
Work Location:Boudry, Switzerland Route de Perreux 1 Boudry 2017
Organization:Celgene R&D Sarl
Shift:Day Job
Employee Status:Regular
Job Type: Standard
Job Level: Manager
Travel:Yes, 5 % of the Time

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

PREREQUISITES BA/BS in a relevant scientific discipline; minimum five years experience as a Data Manager in a pharmaceutical/CRO setting 

Responsibilities will  include, but are not limited to:

1. Functional proficiencies:
Reviews synopsis/protocol and attends Synopsis Review Committee (SRC) meetings
Leads DM study start-up and maintenance activities - CRF design/edit check specifications//external vendor specifications, CRF completion guidelines, (CCGs), coding, IVRS, etc. 
Leads development of site/investigator training materials and present at Investigator Meetings
Leads Celgene team with User Acceptance Testing as applicable
Leads SAE reconciliation
Demonstrates ability to analyze data, share trends/observations with team members around results and relevant metrics
Leads data review and query management 
Prepares the Data Management Plan and essential documentation
Adheres to data standards and proper data validation processes
Performs reconciliation of external data 
Leads database lock activities: inclusive of final SAE reconciliation/final data review, study decommission, etc.
Lead/Participate in regular team meetings and provide input when appropriate
Core study team member and primary contact for data management
Provide input and assist in review/adherence to project timelines 

2. CRO/vendor oversight: 
Provides oversight of vendor activities to ensure quality and timely deliverables
Participates in CRO/external vendor selection
Review Statement of Work (SOW)/contracts
Provides CRO oversight of the data management functional activities and  monitor progress and deliverables
Ensures training on Celgene SOPs, if applicable 

3. Additional Activities:
Participates in writing/reviewing of  functional  SOPs/Working Procedures/Guidance Documents
Leads/participates in department initiatives
Ensures departmental companion groups (Programming, Coding, CDSI, etc.) are consulted appropriately on study decisions
Trains Data Managers on Celgene standards and processes
Liaise with cross-functional teams to provide data management deliverables to health agencies
Participates in submission activities, if applicable 


Knowledge/Competencies Required: 

•         Plans and executes own area of responsibilities through predefined standards and objectives
Work is completed under minimal supervision; routine work may require little to no instruction
Shows solid interpersonal skills and understanding of all project team functions to obtain necessary information from other project team members
Working  knowledge of EDC databases, preferably Medidata RAVE.  Knowledge of J-Review or other reporting tool and basic understanding of SDTM and CDISC
Strong written and oral communication skills
Ability to work in a study team environment
Intermediate knowledge of therapeutic area(s) 
Knowledge of FDA/ICH guidelines and industry standard practices regarding data management