1+ months

Clinical Data Management- New York City

Kelly Services
New York, NY 10167
**Clinical Data Management- contract- New York City**

**100% onsite**

The Clinical Data Management (CDM) Consultant will manage all vendors generating the data using RAVE across clinical trials. The ideal candidate will have a solid experience in data management, programming and statistical experience.

**Position Description:**

Full support of clinical teams (across programs and trials) as subject matter expert on database design and setup within Medidata RAVE EDC or other EDC systems, on study and DB lock data management activities, statistical analysis and provision of on study (interim, DSMC or ad hoc requests) and final data sets and on study data analytics via EDC or other data reporting software tool. The CDM Consultant will manage vendors to ensure efficient data flow within clinical trials.

**Duties and Responsibilities:**

+ Oversight of all relevant vendors (in partnership with Global clinical project managers) across trials, including:

+ EDC vendor- across trials, oversee development (including performance of applicable UAT), maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules system requirements, output management, and reports (standard, custom and ad-hoc)

+ Data management vendor(s) - work across trials (and vendors) to oversee set-up, on study and interim, DB lock activities with DM vendor are consistent and meet the needs and standards of client

+ Statistical Analysis vendors/partners- work across trials (and vendors and/or partners) to oversee consistency of all analysis activities, starting with development of SAPs, outputs for interims, DSMC and DB locks, and provision of submission ready final data sets (assurance that meet standards of CDISC/SDTM, C-DASH and CDISC client Data standards).

+ Data Analytics- work across trials with vendors/systems to ensure Clinical and Medical Monitoring client team members receive periodic information/reports (standard, customized and ad-hoc) as required. Become expert on reporting to support/train members to access data reports directly.

+ Identify, select and maintain a data warehouse vendor with data analysis and programming potential for the organization.

+ Serves as a subject matter expert for escalation of common issues and questions within and across trials with relevant vendor(s) across programs/studies and provide expertise for problem-solving across all areas (EDC/DM/stats/reporting).

+ Contribute to the development and implementation of standard Data Management practices and SOPs as needed.

+ Identify additional opportunities for standardization and efficiency (potentially including research, presentation and recommendations of alternative EDC and/or reporting systems and/or DM/stats/reporting vendors).


**Education and Experience**

+ Minimum of bachelors degree in scientific discipline

+ 8+ years of progressive industry or CRO experience managing clinical databases

+ Minimum of 2-4 years of experience with the Medidata RAVE platform

+ Experience reviewing clinical data to ensure accuracy, completion and integrity of data

+ Experience in programming and in basic statistical analysis

+ Strong leadership skills to manage vendors and ensure integration with the internal Project Team

+ Ability to work independently as an individual contributor and be fully accountable for the Data Management function of the organization

+ Proven ability to work well and effectively in a team global, virtual environment

+ Excellent oral and written communication skills

+ Strong organizational abilities

+ Full-time office-based with limited flexibility to work remotely

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

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit 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.


Posted: 2018-12-14 Expires: 2019-02-14

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Clinical Data Management- New York City

Kelly Services
New York, NY 10167

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