Manager, Clinical Data Management Operations

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 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 specific gene, thereby affecting the production of a specific protein.

Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease.

The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics.

Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA.

Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

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

California pay range

$110,000 $150,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

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