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5 days old

Sr. Clinical Data Analyst

Kelly Services
Warsaw, IN 46582
Kelly Services Outsourcing & Consulting Group is seeking a Sr. Clinical Data Analyst with experience in implementing and editing Medidata Rave custom builds. The Sr. Clinical Data Analyst will be responsible for coordination of timelines and resources required to implement and maintain a variety of clinical systems as well as provide oversight and coordination of all aspects of the development and management of clinical study databases across a variety of platforms. Coordination of activities will require the development of strong, productive relationships with colleagues, this individual performs with little to no supervision. This is an open-ended position with benefits and can be a remote-based for candidates in the Eastern or Central Time Zone. Medidata Rave experience is a must, certification highly preferred and RaveX or RaveEDC is a plus.





**POSITION DUTIES & RESPONSIBILITIES:**




+ Collaborate with Data Management leadership (including Programming and Biostatistics) to define and document data and process standards;

+ Provide in-house project support for creation, routing and approval of all system deliverables associated with clinical systems;

+ Support the development and maintenance of global harmonized processes and procedures for system support;

+ Support global vendor evaluation, selection, contracting, and oversight activities for outsourced systems; Assist with vendor evaluation and selection activities for clinical systems;

+ Work with BSDM partners, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines and milestones for study-specific systems set-up, UAT, maintenance and closeout as required;

+ Lead project management activity related to the deployment of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant platforms (as assigned);

+ Create, review and facilitate approval of system deliverables and facilitate appropriate quality review where applicable;

+ Mentor peers through review of deliverables to minimize delays during the quality review process;

+ Interface between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools;

+ Facilitate support requests associated with clinical systems (as needed);

+ Serve as first line of contact from study initiation through go live for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs;

+ Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes;

+ Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams (as needed);

+ Assist with the implementation of study metrics;

+ Analyzes complex change requests to determine feasibility for incorporation within clinical studies;

+ Evaluates vendor supplied release documentation for implementation feasibility and collaborate with appropriate partners to define project parameters.





**Functional and Technical Competencies** **:**




+ Strong proficiency in more than one clinical system (EDC, CTMS, eTMF and IxRS) is required; Advanced certification preferred;

+ Previous experience in Clinical Operations preferred;

+ Demonstrated ability to manage a project in a team environment to deliver critical milestones;

+ Experience with CDISC STDM preferred;

+ Excellent verbal and written communication skills;

+ Knowledge of GCP and SDLC.





**EDUCATION & EXPERIENCE REQUIREMENTS:**




+ A Bachelors degree (or equivalent) in Statistics, Computer Science or related discipline (required), with at least 6 years of system support in clinical research within Medical Device or

+ Pharmaceuticals.





**Leadership Competencies** **:**




+ Connect Support strategic partnerships with Clinical System and IT leaders at the Enterprise level to ensure MD sector needs are communicated and understood, and with franchise and clinical operations leaders to ensure effective implementation and utilization of systems within the Clinical R&D CoE

+ Shape Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and STDM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine STDM standards

+ Lead Mentor team mates to ensure consistency in process execution and quality system execution

+ Deliver ensure upgrades and maintenance of clinical systems are delivered on time, within budget and in compliance to regulations and SOPs, seamlessly across all Franchises





If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!





**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

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Posted: 2019-08-12 Expires: 2019-09-12

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Sr. Clinical Data Analyst

Kelly Services
Warsaw, IN 46582

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