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Arrowhead Pharmaceuticals
Pasadena, CA, United States
Job Description Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference m
Job Source: Arrowhead PharmaceuticalsBarrington James
Pasadena, CA, United States
BRAND NEW - UPCOMING OPPORTUNITY (Biotech) (San Diego / Pasadena) Manager, Clinical Data Management I am working closely and exclusively with a specialist Biotech who will be looking to hire a Manager, Clinical Data Management soon. The company has a strong Rare Disease / Cardiovascular pipeline, and will be starting a Phase III as well as workin
Job Source: Barrington JamesSmall Biotech
, CA, United States
Summary of the Role: Reporting to the Head of DM, this leader in Data Management will take ownership of a study in early development clinical trials. With a DM environment already established, the right candidate for this role will be able to come in at the ground level, self-manage their study, and help drive the company's exciting pipeline forwar
Job Source: Small BiotechChildren's Institute
Los Angeles, CA, United States
SUMMARY The Data Operations Manager will be responsible for managing our database infrastructure in AWS, executing ETL flows using Alteryx, and ensuring effective data governance practices to support our mission of improving the lives of children and families. ESSENTIAL DUTIES To perform this job successfully, an individual must be able to perform
Job Source: Children's InstituteOaktree Capital
Los Angeles, CA, United States
Our Company Oaktree is a leader among global investment managers specializing in alternative investments, with $189 billion in assets under management as of December 31, 2023. The firm emphasizes an opportunistic, value-oriented, and risk-controlled approach to investments in credit, private equity, real assets, and listed equities. The firm has o
Job Source: Oaktree CapitalL.A. Care Health Plan
Los Angeles, CA, United States
Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Department: Claims Data and Support Services Location: Los Angeles, CA, US, 90017 Position Type: Full Time Requisition ID: 10939 Salary Range: $117,509.00(Min.) -$152,762.00(Mid.) -$188,015.00(Max.) Establ
Job Source: L.A. Care Health PlanZoom Corporation
Los Angeles, CA, United States
What You Can Expect As a Senior Product Manager, you will play a pivotal role in defining and executing our AI strategy. You’ll collaborate with cross-functional teams to create and implement strategic roadmaps for AI and data management. Your expertise in Generative AI, Large Language Models (LLMs), and NLU applications will be critical in delive
Job Source: Zoom CorporationZoom
, CA, United States
What You Can Expect As a Senior Product Manager, you will play a pivotal role in defining and executing our AI strategy. You’ll collaborate with cross-functional teams to create and implement strategic roadmaps for AI and data management. Your expertise in Generative AI, Large Language Models (LLMs), and NLU applications will be critical in delive
Job Source: ZoomPasadena, CA, United States
The Position
The Manager, Clinical Data Management Operations, leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. The assigned clinical trial(s) may be high complexity or high risk. The position is accountable for ensuring study launch, conduct, and closeout are performed according to quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. Duties include serving as the primary data management liaison with vendors and senior management.
Responsibilities
* Serve as the interdepartmental subject matter expert for the CDM Operations area to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval and market acceptance* Lead the following data management activities for multiple clinical development programs: Database transfer, CRF development, Database specifications, User acceptance testing, Query resolution, Data review, Database lock* Manage interface with CROs, clinical sites and laboratories to ensure the efficient and timely collection of clinical data* Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells* Oversee identifying, locating, evaluating and validating CDM documents and databases required for report generation or regulatory submission* Generate data listings or other data review tools for reporting of study metrics* Support clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs, etc* Ensure compliance from a CDM perspective regarding protocols, SOPs and overall clinical objectives; develops SOP as needed* Lead or contribute to the development and implementation of growing departmental policies, standards and process improvement initiatives
Requirements:
* Bachelor's degree* Minimum of 5 years of experience in a fast-paced pharmaceutical/biotechnology position facilitating execution of multiple proof of concept, late stage and post-marketing trials simultaneously* Commitment to quality programs and data-driven program evaluation* Excellent interpersonal (multidisciplinary), written and verbal communication skills* Ability to communicate technical information to a non-technical audience* Working understanding of GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices* Excellent understanding of the clinical trial database life cycle including CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures* Knowledge of CDISC standards, specifically SDTM datasets/SDTM mapping* Thorough knowledge of drug development process from IND to NDA* Good understanding of database and dictionary structures (e.g., MedDRA)* Established experience with EDC vendors and processes
Preferred:
* Master's degree* Supervisory experience* Medidata Rave experience* Expertise in Spotfire or other programming tools
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Email Alert for Manager, Clinical Data Management Operations jobs in Pasadena, CA, United States
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