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11 days old

Lead Data Manager

Kelly Services
Irvine, CA 92604
Kelly Services Outsourcing & Consulting Group is hiring a REMOTE Lead Data Manager for a global device company.



The Lead Clinical Data Manager will be responsible with leading all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets.




+ Independently lead several complex trials;

+ Lead CRF design, review and validation of clinical database, including management of CRO activities in this area as assigned if required;

+ Be responsible for creation of data management plans and other data management documentation as needed;

+ Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines partnering as appropriate with Clinical Operations, Franchise and other BSDM functions;

+ Lead, coordinate, facilitate and manage all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;

+ Proactively organize and manages ongoing data review throughout study conduct, including being responsible for the correction of errors and discrepancies management for the life of a project;

+ Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;

+ Be responsible for identification of data handling processes for non-CRF data, including lab data and image handling;

+ Work with BSDM leadership, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines milestones and budgets;

+ Lead efforts co-ordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;

+ Independently lead new data management initiatives and contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with the project leader data standards to implement;

+ Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;



**Functional and Technical Competencies:**




+ Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.

+ Excellent verbal and written communication skills.

+ Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.

+ Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).



**EDUCATION & EXPERIENCE REQUIREMENTS:**



A Bachelors degree (or equivalent) in the biological sciences, Computer Science or related discipline, with at least 6 years of clinical data management experience in Medical Device or Pharmaceuticals including experience of successful active participation in cross-functional teams.







**This position comes with enhanced benefits which include:**




+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

+ Paid holidays

+ Paid sick days and vacation days*



**Perks of being a Kelly employee:**




+ Weekly electronic pay

+ Access to more than 3,000 online training courses though Kelly Learning center

+ Online application system

+ Never an applicant fee



*benefits to be received upon meeting eligibility requirements



**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.**








**Why Kelly** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-01 Expires: 2019-12-02

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Lead Data Manager

Kelly Services
Irvine, CA 92604

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