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14 days old

Clinical Data Manager

Kelly Services
San Francisco, CA 94103
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Clinical Data Manager** at a prestigious Fortune 500 company working in **San Francisco, CA.**





**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 button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title:** **Clinical Data Manager**





**Responsibilities**



The Manager, Clinical Data Management leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. The Manager, Clinical Data Management is responsible for ensuring study launch, conduct, and closeout are performed according to quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. The assigned clinical trial(s) may be high complexity or high risk. Duties include serving as the primary data management liaison with vendors and senior management. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by senior data management when needed.





**Skills**

Maintain effective communication with vendors and internal project team through oral and written correspondence, project status and progress reports. Manage the planning, implementation and overall direction of executing clinical trial data management activities including protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management. Prepare information for internal meetings.



Maintain and evaluate project progress by managing timelines and other tracking/analysis tools. Design, produce and distribute standard and customized status, resourcing, and tracking reports as well as functional area plans, to appropriate team members and senior management. Work on problems of a diverse scope. Exercise judgment in managing tasks within generally defined practices and policies in selecting methods and techniques to track and manage timelines, risk, and data quality.



Manages the cross-functional collaboration, development, and maintenance of the components of the study Data Management Plan (DMP) and data management deliverables including the Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data review plan, edit check specifications, data transfer specifications, data quality plan, etc. Manage the interaction with data management vendors to ensure that data management tasks remain on target according to project timelines. Proactively organize on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies. Facilitate the correction of errors and discrepancies through the site query process, document permanent data issues, communicate issues with team members, and deliver a quality locked database for analysis. Provide input to the data management study budget and responsible for managing assigned vendor budget(s). Lead new data management initiatives such as establishing capacity for electronic data capture and clinical outcome assessments. Conduct CRO data management function inspections and audits. Contribute to the development and implementation of departmental policies, standards and process improvement initiatives.




**Qualifications** :



A bachelor's degree in clinical, biological or mathematical sciences, nursing degree, or equivalent related field education and experience is required. A master's degree is preferred. A minimum of 8 years actively managing clinical research projects in collaboration with other functional areas with at least 2 years successfully managing CROs is preferred. Previous supervisory, oncology and/or central nervous system experience is preferred. A thorough knowledge of FDA regulations, drug development and clinical monitoring procedures is required. Demonstrated problem solving abilities and strong presentation, documentation, organizational, and interpersonal skills as well as a team-oriented approach are required. Excellent written and verbal communication skills are required. Demonstrated proficiency with ICH, GCDMP, and GCP is required. Fluent English is required. Proficient computer skills using Word, Excel, PowerPoint, MS Project, email and the internet are required. Demonstrated self-starter with the ability to mentor and handle multiple tasks to meet deadlines while delivering high quality work in a dynamic work environment. Must possess excellent project management skills and have demonstrated ability to develop data management processes and training.





**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**





**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**



**Kelly Services is an Equal Opportunity Employer**










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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding 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 90 of the Fortune 100 companies and found opportunities for more than 10,000 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.




**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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-10-07 Expires: 2019-11-07

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Clinical Data Manager

Kelly Services
San Francisco, CA 94103

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