Contract Clinical Trial Manager
Position description and scope:
The successful candidate will have experience working as a member of a cross-functional team and managing Contract Research Organizations (CROs). Reporting to the Director, Clinical Operations the incumbent will be responsible for effectively supporting ongoing clinical trials in renal disease.
- Coordinate, manage, and oversee all activities on clinical projects including managing CROs and vendors.
- Ensure compliance with regulatory agency, ICH, and GCP guidelines.
- Identify prospectively any issues that will interfere with meeting project goals and recommend solutions.
- Bachelor’s degree in a life science or its equivalent in health care or biological science.
- Minimum of three years of clinical operations experience in the biotechnology or pharmaceutical industry.
- Excellent working knowledge of Good Clinical Practices; ICH guidelines; trial initiation and management practices and procedures;
- Excellent leadership, interpersonal and communication skills. Works efficiently with others to accomplish goals and resolve problems. Encourages cooperation, collaboration, and co-ownership of processes. Innovative problem solver.
- Ability to work on complex problems
- Willing to travel for training, various monitoring visits (including SIVs), and/or to assist with complex, difficult clinical sites
- Effective interpersonal skills, including both written and oral communication skills
- Highly organized, strong analytical skills, highly attentive to details, and strong work ethic
- Ability to work within schedules and deadlines
- Team player, intensely committed to success and getting the job done well in a highly dynamic environment
- Ability to manage multiple projects, prioritize, and function in a fast-paced entrepreneurial environment
- Self-motivated, ability to work independently while also willing to follow protocols
Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a rich intellectual property estate to retain its leadership in the microRNA field. Regulus is advancing several programs in renal, hepatic and central nervous systems diseases.
Regulus is located in La Jolla, California and is led by a seasoned executive team experienced in corporate management, business, science, drug discovery and development. Regulus' scientific advisory board consists of world-class scientists and some of the foremost authorities in the field of microRNA research.
For immediate consideration, please apply to firstname.lastname@example.org
You can visit our website to find out more about our company and culture: www.RegulusRx.com.
Reference job code: 562
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Regulus Therapeutics, Inc, is proud to be an EEO Employer.