CenterWatch

19 days old

Clinical Data Manager

Kelly Services
South San Francisco, CA 94080
Kelly Services has an IMMEDIATE opening for a Sr. Clinical Data Manager (CDM). This is a one-year assignment based in South San Francisco, CA. All work must be done onsite, no remote. The CDM is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT, study conduct through database lock for assigned studies.





The core duties and responsibilities of the CDM:



Participates in the development, review and implementation of departmental SOPs, templates and processes



Supports budget and resource planning across assigned projects



Contributes to technical infrastructure of data management



Participates in CRO/vendor selection process for outsourced activities



May participate in department or cross-functional initiatives



Represents data management in study team meetings



Manages data management timelines, including timelines of external data reconciliations, to coordinate and synchronize quality deliverables with the overall study timelines



Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case



Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)



Executes and/or distributes data management metrics, listings, and reports.



Oversight of data management CRO/service providers on assigned studies, including providing feedback and clear direction on data issues and deliverables



Monitors the progress of all data management activities on assigned studies to ensure project timelines are met, including progress of external data reconciliation issues



Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed



Reviews study metrics, listings, logs, and other data outputs to proactively identify potential study issues/risks, sources of these risks, recommends clear solutions, and executes according to decisions



Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal



Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors and data sources



Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables







Requirements





Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements



Excellent verbal/written and interpersonal skills required for working successfully in a cross- functional team environment and managing quality deliverables from external vendors.



Able to articulate complex data issues and solutions clearly with cross-functional teams in face-to-face conversation, by telephone, and by email



Able to creatively formulate alternative solutions and/or strategies to move complex data issues to resolution.



Experience in providing guidance and training to CROs, vendors, and investigational sites



Demonstrated project management experience with the ability to perform under tight timelines while balancing conflicting priorities



Highly motivated, self-starter, detail-oriented, and critical thinker



Good working knowledge of ICH, FDA, and GCP regulations and guidelines



Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)



Knowledge of industry standards (CDISC, SDTM, CDASH)



Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.



Proven ability to work both independently or in a team setting





Education/ Training



Bachelors degree in Life Sciences, Computer Sciences, Mathematics, or health-related field



Minimum of 5 years of SENIOR-LEVEL DM experience in the pharmaceutical or biotechnology industry or equivalent; depth and exposure to DM related tasks considered in lieu of minimum requirement



CRO/vendor management experience required



Competence in SAS programming a plus



Prior oncology/hematology experience highly desirable





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





Perks of being a Kelly employee:



Weekly electronic pay



Access to more than 3,000 online training courses though Kelly Learning center



Group rate insurance options available immediate upon hire*



Service bonus plan and holiday pay*



Online application system



Never an applicant fee





*perks 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** **** **?**



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
Posted: 2019-10-25 Expires: 2019-11-25

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Clinical Data Manager

Kelly Services
South San Francisco, CA 94080

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