PaloAltoRecruiter Since 2001
the smart solution for Palo Alto jobs

Associate Director, Data Management

Company: Jazz Pharma
Location: Palo Alto
Posted on: October 16, 2020

Job Description:

Job Description Overview: Jazz Pharmaceuticals 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 you're 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 you'll explore our career openings and get to know Jazz Pharmaceuticals. Responsibilities: The Associate Director, Data Management will oversee the data management of clinical trials in a particular therapeutic area or development program. S/he may also lead critical studies in this area of responsibility. S/he will provide oversight to the daily operations of Jazz Pharmaceuticals' clinical programs through vendors. S/he may lead a team of data management professionals and will be expected to provide vision, leadership, and mentoring to their assigned team. S/he will facilitate effective internal and external relationships. S/he will be expected to contribute extensively to the development and growth of the Data Management group within the Clinical Operations structure Essential Functions * Oversee (and sometimes lead) the data management of Phase 1 through 4 clinical trials in a particular therapeutic area or development program * Develop and implement methods to demonstrate oversight of CROs and other vendors * Provide direction and leadership in CRO and vendor selection and management. * Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Protocols, Centralized Monitoring 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 data management resources within the area of responsibility * Provide vision, leadership, and mentoring to staff assigned to his/her line management * Participate in and/or lead the development and implementation of standards and processes related to both clinical data and risk-based trial management * Participate in the generation and approval of budgets and timelines Required Knowledge, Skills, and 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 and Licenses * BA/BS required, preferably in the scientific/healthcare field. * At least ten years' experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment * Several years of study lead and supervisory experience Description of Physical Demands * Occasional mobility within office environment. * Routinely sitting for extended periods of time. * Constantly operating a computer, printer, telephone and other similar office machinery. Description of Work Environment * Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes. * Frequent computer use at workstation. * May move from one work location to another occasionally. * Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands. Occasional public contact requir

Keywords: Jazz Pharma, Palo Alto , Associate Director, Data Management, Other , Palo Alto, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


MERCHANDISING
Description: Job Description Merchandising Execution Associates: All Merchandising Execution Associates MEAs perform in-store merchandising service activities such as merchandising projects, planogram maintenance, (more...)
Company: The Home Depot
Location: Woodland
Posted on: 10/28/2020

Data and Impact Specialist
Description: If you're a data expert who can track, analyze and measure data and outcomes and design systems, check out this opportunity to join our team and help rural communities as a Executive
Company: Rural Community Assistance Corporation
Location: West Sacramento
Posted on: 10/28/2020

High Demand For Quality Handymen - Get New Clients In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Woodland
Posted on: 10/28/2020


Refrigerated Truck Driver CDL-A Recent Grads - Delivery Food and Supplies!
Description: Job Description Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join
Company: C.R. England
Location: West Sacramento
Posted on: 10/28/2020

Caregiver
Description: Job Description Home Instead Senior Care is looking for caring and compassionate
Company: Home Instead
Location: Woodland
Posted on: 10/28/2020

ReactJS Developer
Description: Hi Techie, If you are seeking a new opportunity, I do have one, Please refer to the below position with my direct client. Duties - Designs, develops, and implements software packages for websites. Troubleshoots
Company: Accion Labs
Location: West Sacramento
Posted on: 10/28/2020

Req: Full Stack Java Developer
Description: Full Stack Java Developer Duration 4 Months possibility of extension Location Woodland Hills, CA Position Application Developer IV Full Stack Developer Independent Candidate JOB SUMMARY Develop API (more...)
Company: OnwardPath Technology Solutions LLC
Location: West Sacramento
Posted on: 10/28/2020

Urgent requirement for The Home Depot Merchandising in The Home Depot in West Sacramento
Description: The Home Depot Merchandising - The Home Depot Job DescriptionMerchandising Execution Associates:All Merchandising Execution Associates MEAs perform in-store merchandising service activities such as (more...)
Company: The Home Depot
Location: West Sacramento
Posted on: 10/28/2020

Become an OTR CDL-A Truck Driver Trainer - Refrigerated, Safest in Trucking!
Description: Job Description Hiring Driver Trainers to Train New Truck Drivers Refrigerated Trucking is one of the safest bets in the trucking industry as it relates to jobs. The country
Company: C.R. England
Location: West Sacramento
Posted on: 10/28/2020

Recent Grad CDL-A Truck Driver - Refrigerated, Safest in Trucking!
Description: Job Description Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join
Company: C.R. England
Location: Woodland
Posted on: 10/28/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Palo Alto RSS job feeds