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


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

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Clinical Data Manager

Kelly Services
South San Francisco, CA 94080

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast