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9 days old

Senior Clinical Data Manager

Kelly Services
Palo Alto, CA 94301
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship.


Kelly Science & Clinical is seeking a Senior Clinical Data Manager to join their team in Palo Alto, CA for a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. For immediate consideration, please email your resume directly to: Regan.Brown@KellyServices.com as well as apply online.


**Senior Clinical Data Manager**


**Permanent** **(direct hire W2)**

**Pay Rate: BOE/TBD**


Overview:


Company is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Company is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.



We are looking for the best and brightest talent to join our team. If youre looking to be a part of a company with an unwavering commitment to improving patients lives and being a great place to work, we hope youll explore our career openings and get to know Company.


Responsibilities:


The Senior Clinical Data Manager will be responsible for performing Data Management activities that support Companys commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance. The Senior Clinical Data Manager will:


+ Be able to lead a large clinical study or a series of related studies with minimal guidance.

+ Represents Data Management on the CTWG for assigned studies.

+ Provide mentoring and training to lower level Data Management staff assigned to his/her studies.

+ Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO/vendor counterparts.

+ Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.

+ Be able to perform a thoroughly detailed review of eCRF data requirements.

+ Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.

+ Lead the development of data edit check specifications and data listings.

+ Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members.

+ Develop or lead the development of the Data Management Plan for a clinical study.

+ Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.

+ May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.

+ Perform reconciliation of header data from external data sources against the clinical database.

+ Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.

+ Lead database upgrades/migrations including performing User Acceptance Testing.

+ Be able to maintain study workbooks and data management files.

+ Perform database lock and freeze activities per company SOPs.

+ Participate in regular team meetings and provide input when appropriate.

+ Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents.

+ Contribute to a professional working environment including the application of Company Code of Business Conduct and Ethics.

+ Assist with the training of new employees and/or contractors.


Essential Requirements **:**


+ Bachelors Degree required (Master's Degree preferred) in the scientific/healthcare field.

+ At least five years experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience.

+ Has good project management skills and a proven ability to multitask.

+ Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform most of the core Data Management tasks and interact with vendors.

+ Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.

+ Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

+ Possesses strong English language written and verbal communication skills.

+ Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are preferred.

+ Able to travel to off-site meetings or training seminars as needed.

+ Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.


**Why Kelly:**


As a Kelly Services employee, you will have access to numerous perks, including:


+ Exposure to a variety of career opportunities as a result of our expansive network of client companies.

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career.

+ Access to more than 3,000 online training courses through our Kelly Learning Center, including accredited courses to obtain IT certifications, as well as PDU-approved courses.

+ Weekly pay.

+ Group-rate insurance options available immediately upon hire.*


**Apply today!**


**Refer a friend!**


*Available for purchase and administered by a designated third-party vendor.


**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)
Posted: 2021-06-11 Expires: 2021-07-12

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Senior Clinical Data Manager

Kelly Services
Palo Alto, CA 94301

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