Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specified gene, thereby affecting the production of a specific protein. Our RNAi-based therapeutics are at the leading edge with the potential to bring life changing treatments for patients.
Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on targeted RNA delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety.
Our employees are nimble, science-driven, innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics in a variety of indications to add to our growing pipeline.
Arrowhead’s corporate headquarters along with its clinical and regulatory operations are located in Pasadena, CA just north of Los Angeles. Pasadena rests in the foothills of the San Gabriel Mountains and boasts incredible natural scenic beauty. Pasadena is also known for its vibrant cultural and academic offerings as well as its rich architectural heritage.
The Clinical Data Manager coordinates in-house data management activities (including vendor management) to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. In addition, the position is responsible for building programs to create datasets, listings, tables and figures from clinical databases, external data sources, and other sources.
Key Duties and Responsibilities:
- Receive data from external data sources.
- Prepare data reports, tables and graphs for regulatory submissions, IRB submissions, presentations and publications.
- Maintain traceability of data sets used for various reports.
- Perform consistency checks and data cleaning functions.
- Review data on a regular basis for trends and relationships.
- Liaise with Clinical research teams on data
- Work with other functional groups, such as Program Management, Regulatory Affairs and Research to ensure data management aspects of projects are properly considered and integrate well with other activities.
- Validate analysis datasets, tables, listing and figures.
- Perform quality control on final output.
- Preparation of safety listings for ad hoc/periodic “events of interest” analysis and routine safety data monitoring for weekly and bi-annual reviews.
- Preparation of data listings to support periodic and development regulatory activities (e.g., FDA Annual Reports, DSURs).
- Prepare TLGs as well as ISEs and ISSs for regulatory submissions.
- Support Clinical Operations with management of DM vendors including development and maintenance of Clinical Data Management Plans, CRF completion guidelines, Statistical Analysis Plans, etc.
- Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.
- Review CRF annotations and data specifications.
- Establish and maintain a working environment which fosters open communication, collaboration, integration, and teamwork.
- Excellent interpersonal, communication and organizational skills with the ability to work independently and in a team environment
- Complex problem solving skills
- Solid vendor management skills
- Ability to prioritize activities and multi-task across various projects that will be at different study stages
- Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
- Must be able to work with distributed team members and outside vendors such as clinical research organizations.
- BS degree (health-related field preferred). Clinical SAS programming experience may substitute for the post-secondary educational requirement
- At least 3 years data management experience in the pharmaceutical, biotechnology, or contract research organization industries
- Excellent Excel skills
- Familiarity with Base SAS, SAS/Graph, SAS/Stat and ODS
- Previous experience with EDC required
- Overall understanding of ICH GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials and clinical research
- Familiarity with CDISC, SDTM and ADAM
- MedDRA and WHO Drug coding proficiency helpful but not required
- Basic knowledge of statistics helpful but not required
Please submit a resume and cover letter to firstname.lastname@example.org.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the U.S. for a company.