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15 days old

Sr. Manager/Associate Director Data Management

Kelly Services
New York, NY 10176
**Kelly Services is currently seeking a Sr. Manager/Associate Director Data Management (title depends on experience) for a 12 month assignment in NY, NY.**


**ROLE OVERVIEW**


Accountable for Data Management deliverables from end to end and for ensuring excellence in Data Management and Data Cleaning activities, in terms of quality, timelines and budget for clinical trials.


Ensure managing and leading more junior Data Managers in terms of processes, roles, responsibilities, and personal development.


Maintain overall responsibility for the quality and completion of all projects within the Data Management group.



**RESPONSIBILITIES:**


Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.


+ Leadership of the data management tasks for all clinical studies

+ Provide operational input into study design, protocol development and study planning

+ Manage timelines for data management activities, for both outsourced and internally-resourced clinical studies, ensuring quality and timely delivery

+ Oversee and provide direction for data management activities for outsourced clinical studies and serve as lead data manager for assigned studies

+ Ensure data management activities are conducted according to applicable regulations and per protocol

+ Oversee or develop data management plans

+ Oversee or execute CRF development, database set-up activities, data validation process, UAT, medical coding and SAE reconciliation

+ Oversee or develop eCRF completion guidelines and provide training to study site personnel

+ Oversee or develop data transfer agreements and specifications with external data vendors

+ Ensure consistency in data collection and processes across studies/programs, as appropriate

+ Oversee data review activities (data cleaning and external data review/reconciliation) and ensure completion of all activities leading to study database lock

+ Track data management issues and ensure resolution and documentation

+ Communicate with relevant functions regarding study status/issue resolution

+ Oversee or execute archival of data and study-specific data management documentation

+ Potential to build in-house team of data managers as the portfolio grows.

+ CRO and FSP oversight in order to have deliverables meet or exceed business objectives with respect to cost, quality and timelines

+ Participate to the collaboration between relevant functions (Clinical Operations, Clinical Science, Pharmacology, Biostatistics, Regulatory Affairs,) to produce compliant datasets for regulatory submission.

+ Ensures appropriate and consistent application of SOPs, standards and quality and compliance measures.


**EDUCATION AND DESIRED EXPERIENCE:**


+ Minimum BS or MSc level, with at least 7 years experience in Clinical Data Management and a minimum of 2 years of supervisor experience is preferred

+ Demonstrated knowledge of the Data Management aspects of the pharmaceutical, biotechnology, and/or clinical research service industries.

+ Demonstrated knowledge of clinical research processes and methodologies, including an understanding of current GCP/ICH guidelines applicable to the conduct of clinical research.

+ A high-level of self-direction and judgment related to the execution of duties and responsibilities.

+ Ability to communicate effectively with internal and external parties and maintain positive and open relations.

+ Ability to create presentations and effectively present information

+ People management experiences is preferred

+ Experience overseeing contractor/CRO activities

+ Experience in standardization of clinical collections and submission modules

+ Proficient experience and demonstrated experience using clinical data management tools such as Medidata Rave

+ Technical experience in programming tools is desirable

+ Project management experience

+ Strong communications skills and ability to promote the advantages of Data Standards to all functions.

+ Ability to effectively multitask across projects and be proactive and innovative

+ Ability to influence peers and senior managers

+ Ability to work cross culturally and across geographies

+ Diplomatically assertive and clear communicator.

+ Demonstrated knowledge in CDISC standards


**APPLY NOW!**


**For immediate consideration, please send your resume in a WORD document to gaut985@kellyservices.com**


\#TJP2021_SPEC


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-10-06 Expires: 2021-11-06

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Sr. Manager/Associate Director Data Management

Kelly Services
New York, NY 10176

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