Senior Manager, Data Management job Woodcliff Lake New Jersey
Senior Manager, Data Management job Woodcliff Lake New Jersey
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Senior Manager, Data Management Job



Employer Name: SpiderID: 7621586
Location: Woodcliff Lake, New Jersey Date Posted: 6/4/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH27087

Job Description:

Job Summary



  • The Neuroscience and General Medicine product creation unit within the Company is currently seeking a Sr. Manager, Data Management opening at its North American Headquarters in Woodcliff Lake, NJ.

  • Remote 1 day a week. May be flexible with more after a few months of service


Responsibilities



  • This role will 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 Company 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.

  • 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.


Qualifications
Education



  • Bachelor degree or above in scientific or related field


Experience



  • Minimum 5-8 years' experience in Data Management with experience in managing projects, project teams.

  • Qualified candidates will have had broad experience in the neuroscience area. Experience specific to Alzheimer Disease and Epilepsy related studies is highly preferred.

  • Experience with In-Form or other EDC software.

  • Experience in supporting NEURO studies preferred.

  • EDC experience required.

  • Inform preferred.

  • Manage CRO activities.


Skills



  • 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.

  • 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 Company standards.




Please submit your resume for consideration. Once submitted, feel free to contact Rushi at 858-703-6733 for additional information.

Approx. Duration: 12 months

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

As the staffing industry evolves, Hired by Matrix continues to develop and grow. By combining our expertise with a keen understanding of each client's needs we are able to source for the most qualified candidates. Our commitment to servicing our clients corresponds with our commitment to finding the perfect match between our clients and candidates and maintaining our relationships long term.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

Connect with us on LinkedIn and see how we can impact your career!
Hired by Matrix Career Center: http://bit.ly/HbMCareers



Job Criteria:
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Position Type: Contractor
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Contact Name: Hired by Matrix, Inc. Company Type:
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