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20 days old

Clinical Contract Specialist

Kelly Services
Foster City, CA 94404
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as an **Clinical Contracts Associate??** at a prestigious **BioPharmaceutical** company working in **Foster City, CA.**



This is a 6-month contract position at 40 hours per week.



**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 now button below to submit your resumes.



**Job Description:**



The Development Business Operations Associate II in the Document Management Team DMT will collaborate with Development Business Operations functional groups, Clinical Records, Clinical Operations Teams, and Development Business Operations functional groups in the planning, development, and implementation of standards, processes, and projects for DMT designed to ensure the effective and efficient archiving of clinical agreements and related information.




+ Comply with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.

+ Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements

+ Collaborate with Development Business Operations leadership

+ Development Business Operations functional groups, clinical operations teams, and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the practices of customer records management/TMF archival initiative

+ Work with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements e.g. filing of agreements in customer legal archive, Apttus, and eTMF GDAR system

+ Data mining/modeling e.g. statistical models and enhancing data collection procedures to identify patterns and extract knowledge from large data sets Processing, cleansing, and verifying the integrity of data used for analysis

+ Doing ad-hoc analysis of department data and presenting results in a clear manner

+ Work with management to manage business continuity procedures, including management of paper agreements

+ Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol agreements from TMF room for Apttus filing Collaborate with management to generate central intake report on a daily and published in a timely fashion

+ Responsible for keeping DMT Master Inventory up to date and accurate

+ Evaluate regulatory and customer business recordkeeping, archiving requirements, and organizational objectives and ensure

+ Development Business Operations DMT is aligned with all Responsible for the continued maintenance of eTMF GDAR and Apttus contract filing

+ File incoming documents and retrieve copy of paper protocol agreements from TMF room for Apttus filing

+ Ensure record filing is kept up to date is performed accurately by DMT members

+ Work with management to develop and maintain quality assurance and control plans

+ Responsible for monitoring accuracy of the team s work by providing reports and metrics to management team

+ Potential lead of assigned meetings/projects and will mentor/help more junior staff with complex projects

+ Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents

+ Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying clinical records

+ Manage the off-site storage of records for Development Business Operations agreements and collaborate closely with customer Clinical Records team to ensure proper process is in place for off-site archival of paper agreements

+ Collaborate and partner with the Information Technology IT GDAR Team, through stellar communication and solid project management.

+ Resolve efficiently any issues encountered by collaborating with IT in the improvement of processes, procedures, and effective use of available information technologies

+ Operate as the Subject Matter Expert SME in the electronic TMF eTMF




**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-11-11 Expires: 2020-12-12

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Clinical Contract Specialist

Kelly Services
Foster City, CA 94404

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