Description:
Contribute to protocol, and create study and therapeutic specific documents.
Oversee database start up activities and ensure completion is in accordance with Neuroscience Business Group metrics and companies Data Management standards.
Ensure other Data Managers are trained and oversee the quality of all DataBase start up standard essential documents and activities.
Manage the work of outsourcing vendor and will approve the following key standard study documents: CCGs, DataBase clean plan, check validations, User Acceptance plans, eCRF development and DB lock plans.
Edit check validations.
Oversee the day to day activities of outsourced Data Managers to effectively clean all data captured in the eCRF. the process of vendor reconciliation, and problem solving needed to engage Vendors to meet timelines and produce quality data.
This person is a key member of the study team, and will act as an advisory regarding technical DB issues and any post productions changes needed to update DB structure due to protocol amendments, etc. Create vendor data transfer specifications and follow up with vendors regarding discrepancies.
Attend Investigator meetings, and present on eCRFs, train site personnel on working in an eDC environment.
The Senior Manager, DM is expected to be a therapeutic expert and to train vendor accordingly The Senior Manager, CDM will need to understand the big picture of clinical trials and work closely with Statistics, ClinOps and Clinical.
Sr. Manager, CDM will design and program data clean listing using jreview, and understand the basics of STDM to communicate effectively with Data Operations.
Bachelor degree or above in scientific or related field Minimum 5-8 years’ experience in Data Management with experience in managing projects, project teams. Experience with In-Form or other EDC software. Experience in supporting NEURO studies a plus. Must be able to work independently. Proficiency on all related regulations, GCP, and Good Clinical DM Practice. Project management skills required. Strong oral and written communication skills. - Leadership skills a must. Must be able to interpret protocols and conduct edit checks. EDC experience required. Inform preferred. Manage CRO activities.
Work from home 1 day a week.
Min 5-8 years experience.
Qualified candidates will have had broad experience in the neuroscience area. Experience specific to Alzheimer Disease and Epilepsy related studies is highly desirable. The Sr. Manager DM is primarily responsible for the direct management of clinical study activities as they relate to data collection and processing from study start up through ongoing oversight to completion. In support of the above, the Sr. Manager reviews protocols to ensure consistency, develops and leads site investigator training, and performs user acceptance testing. He/she must manage SAE reconciliation, process external data, oversee development of metric reports, medical coding etc. Candidates must have proven ability to work collaboratively across functions, business units, data operations, and vendors. In addition, the candidate will contribute to the enhancement of a data standards library within the neuroscience and general medicine unit.
Working in a highly matrixed environment, the successful candidate must have proven ability to effectively manage outsourced vendor activities as well as internal resources. The candidate must be capable of managing and leading others, providing appropriate feedback when warranted, setting clear direction for team members and appropriately assigning resources to meet work objectives. This individual may also act as “compound lead” for select projects to ensure consistency in the DB build across all protocols, ensuring conformity to companies standards.
Oversee database start up activities and ensure completion is in accordance with Neuroscience Business Group metrics and companies Data Management standards.
Ensure other Data Managers are trained and oversee the quality of all DataBase start up standard essential documents and activities.
Manage the work of outsourcing vendor and will approve the following key standard study documents: CCGs, DataBase clean plan, check validations, User Acceptance plans, eCRF development and DB lock plans.
Edit check validations.
Oversee the day to day activities of outsourced Data Managers to effectively clean all data captured in the eCRF. the process of vendor reconciliation, and problem solving needed to engage Vendors to meet timelines and produce quality data.
This person is a key member of the study team, and will act as an advisory regarding technical DB issues and any post productions changes needed to update DB structure due to protocol amendments, etc. Create vendor data transfer specifications and follow up with vendors regarding discrepancies.
Attend Investigator meetings, and present on eCRFs, train site personnel on working in an eDC environment.
The Senior Manager, DM is expected to be a therapeutic expert and to train vendor accordingly The Senior Manager, CDM will need to understand the big picture of clinical trials and work closely with Statistics, ClinOps and Clinical.
Sr. Manager, CDM will design and program data clean listing using jreview, and understand the basics of STDM to communicate effectively with Data Operations.
Bachelor degree or above in scientific or related field Minimum 5-8 years’ experience in Data Management with experience in managing projects, project teams. Experience with In-Form or other EDC software. Experience in supporting NEURO studies a plus. Must be able to work independently. Proficiency on all related regulations, GCP, and Good Clinical DM Practice. Project management skills required. Strong oral and written communication skills. - Leadership skills a must. Must be able to interpret protocols and conduct edit checks. EDC experience required. Inform preferred. Manage CRO activities.
Work from home 1 day a week.
Min 5-8 years experience.
Qualified candidates will have had broad experience in the neuroscience area. Experience specific to Alzheimer Disease and Epilepsy related studies is highly desirable. The Sr. Manager DM is primarily responsible for the direct management of clinical study activities as they relate to data collection and processing from study start up through ongoing oversight to completion. In support of the above, the Sr. Manager reviews protocols to ensure consistency, develops and leads site investigator training, and performs user acceptance testing. He/she must manage SAE reconciliation, process external data, oversee development of metric reports, medical coding etc. Candidates must have proven ability to work collaboratively across functions, business units, data operations, and vendors. In addition, the candidate will contribute to the enhancement of a data standards library within the neuroscience and general medicine unit.
Working in a highly matrixed environment, the successful candidate must have proven ability to effectively manage outsourced vendor activities as well as internal resources. The candidate must be capable of managing and leading others, providing appropriate feedback when warranted, setting clear direction for team members and appropriately assigning resources to meet work objectives. This individual may also act as “compound lead” for select projects to ensure consistency in the DB build across all protocols, ensuring conformity to companies standards.