Clinical Data Manager in Carpinteria, CA

$80K - $100K(Ladders Estimates)

Agilent Technologies   •  

Carpinteria, CA 93013

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 54 days ago

In the Companion Diagnostics Business (CDx), our team partners very closely with leading pharmaceutical companies to develop, manufacture and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients.

Become a part of a growing and dedicated team that does truly inspiring work in the field of Precision Medicine. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer.

We are searching for an experienced Clinical Data Manager to work within the exciting field of oncology Companion Diagnostics (CDx). As a Clinical Data Manager your main responsibilities will be to lead the data management efforts of the clinical sciences team, determine clinical strategy in conjunction with team members, write clinical protocols, extract and analyze data and write reports to support the clinical documentation of CDx in the field of tissue-based Cancer Diagnostics. The top candidate will have a strong background in biostatistics/data management and experience working in oncology drug, biomarker or in vitro diagnostic clinical development. The candidate will work directly with pharmaceutical partners, clinical and R&D scientists, biostatisticians, clinical trial managers and regulatory affairs specialists to assure compliance with internal and external requirements.


The successful candidate will be measured on:


The ability to act as a technical leader on aspects of data management in the development of companion diagnostic devices.

The ability to streamline and optimize data management processes by ensuring subject matter expert supervision.

The ability to assist in the development of clinical data models and annotation of Case Report Forms (CRFs) for clinical studies that utilize cancer diagnostics.

The ability to troubleshoot problems related to the quality and completion of data for clinical trials and analytical validation studies.

The ability to contribute to the clinical strategy for CDx products.

Your professional interactions and communication skills with pharmaceutical partners and regulatory bodies, such as the FDA.

The ability to work in a fast-moving self-driven team.

The ability to write and interpret clinical protocols, reports and provide data analysis.

Job Type

Experienced

Schedule

Full-time

Shift

Day Job

Travel Required

Occasional

Qualifications

Required Qualifications:

  • Bachelor's, Masters, or Univeristy degree or equivalent in pharmaceutical, medical or other relevant biological science
  • 4+ years of experience in clinical studies for diagnostic, medical device or pharmaceutical products
  • Experience in development of standardization processes in data science/data management areas including development of Standard Operating Procedures for Data Management, Data Management Plans, Quality Management Plans, and electronic Case Report Forms (eCRFs).
  • Experience with testing data management systems including editing data validation checks as well as user acceptance testing (UAT).
  • Experience with data visualization techniques.
  • A solid knowledge of clinical study design, clinical data management, biostatistics and Good Clinical Practice.
  • Solid knowledge of electronic data management collection tools (e.g. experience with Medidata RAVE)
  • Experience in R or SAS based data analyses and developing relational databases
  • Experience in working in parallel projects teams.
  • Experience from working with external, international partners.
  • Advanced skills in both written and spoken scientific/technical communication.

Preferred Qualifications:

  • Master's or PhD in pharmaceutical, medical or other relevant biological science
  • Experience in supervised and unsupervised machine learning, statistical/mathematical modeling
  • Knowledge of oncology and/or pathology
  • Experience in SQL and/or Python

Preferred location is Carpinteria, CA but will consider remote work for well qualified candidates. High work capacity may be required at certain times in high priority projects.


Valid Through: 2019-10-16