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2 days old

Senior Manager, Clinical Data Management

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 Manager Clinical Data Management 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 Manager Clinical Data Management**


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

**Pay Rate: BOE/TBD**


Overview:


Company is an international biopharmaceutical company focused on improving patients lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.



Our therapeutic areas of focus include sleep and hematology/oncology areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.



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 Sr. Manager, Clinical Data Management (Sr. Manager, CDM) will oversee the data management of clinical trials in a large or complex development program. S/he may also lead critical studies in this area of responsibility. S/he will provide oversight to the daily operations of Companys clinical studies through vendors. S/he may lead a small team of junior and senior Clinical Data Managers and/or lead a technical development area (e.g. process, innovation, training, etc.). S/he will facilitate effective internal and external relationships. S/he will be expected to contribute to the development and growth of the CDM group within the Clinical Development Operations (CDO) structure. S/he will fulfill the following functions: Essential Functions:


+ Oversee (and sometimes lead) the data management of Phase 1 through Phase 4 clinical trials in a large or complex development program.

+ Provide leadership, and mentoring to junior and senior Clinical Data Managers assigned to his/her line management.

+ Participate in and/or lead the development and implementation within a technical development area (e.g. process and standards, innovation, training, etc.).

+ Represent Clinical Data Management on the Development Core Team and/or Clinical Trial Working Groups as appropriate.

+ Provide input to the development and implementation of methods to demonstrate oversight of CROs and other vendors, and manage and/or monitor the progress of outsourced data management activities.

+ Provide input and direction in CRO and vendor selection and management.

+ Provide technical expertise for the development of data management and other clinical trial documents (Clinical Data Management Plans and associated documents, Protocols, Centralized Monitoring Plans, Statistical Analysis Plans, etc.) and trial conduct.

+ Be responsible for and manage data management activity of Clinical Data Managers assigned to his/her trials.

+ Ensure that the Data Management component of the TMF and other documentation required to support regulatory submissions and inspections are maintained to the standard required.

+ Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence.

+ Contribute to strategic planning to ensure optimized use of clinical data management resources within the area of responsibility.

+ Participate in the generation and approval of budgets and timelines.


Required Knowledge, Skills, & Abilities:


+ Thorough knowledge of data management and its role in the drug development process.

+ Understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with data management.

+ Experience of all stages of a clinical trial and vendor oversight.

+ Experience of managing and mentoring clinical data managers.

+ Demonstrated knowledge of ICH/GCP guidelines as they relate to data management.

+ Thorough understanding of CDISC CDASH and SDTM standards.

+ Extensive experience managing CROs and other data vendors.

+ Experience working with a globally distributed team.

+ Ability to work on and solve complex problems.

+ Ability to prioritize and handle multiple tasks simultaneously.

+ Effective leadership skills and proven ability to foster team productivity and cohesiveness.

+ Excellent communication/interaction skills and experience in a dynamic and growing organization.

+ Travel Required.


Required/Preferred Education & Licenses:


+ Bachelors Degree required (Masters Degree preferred) in the scientific/healthcare field.

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


**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 Manager, Clinical Data Management

Kelly Services
Palo Alto, CA 94301

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