Clinical Program Manager

Location
Pleasanton, CA
Posted
Oct 17, 2018
Required Education
Bachelors Degree
Position Type
Full time

Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals, www.astx.com, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. This position will be based in our office located in Pleasanton, California near the Dublin-Pleasanton BART station in the Rosewood Commons campus: http://www.rosewoodcommons.com/transformation.html

The Clinical Program Manager will be responsible for overseeing all aspects of an Astex Pharmaceuticals’ clinical program. This role will partner with the Astex Clinical Operations staff and other departments to ensure that Astex clinical trials are conducted in accordance with corporate Standard Operating Procedures (SOPs) and Guidelines, Good Clinical Practices (GCP), ICH Guidelines and applicable federal and national regulations (FDA and EMEA).

Responsibilities:

• Day-to-day management of clinical studies within assigned program; site selection, study implementation, management of CROs/vendors, ongoing management of study sites either directly or via service providers

• Organize and lead internal clinical study team meetings, and represent the Clinical Study Team at Project Team meetings

• Coordinate and/or participate in Investigator meetings, site initiation visits, and co-monitoring

• Train study coordinators and investigators on Good Clinical Practice/ICH and Astex processes

• Prepare Investigator Brochures, manuscripts, safety, interim, and final study reports

• Participate in forecasting study drug supply requirements and managing logistics, budget planning and tracking, and development of best practices for Phase 1-3 study management

• Determine methods and procedures for new assignments with minimal supervision

• Proactively minimize risks

• Exercise sound judgment within defined practices and policies for selecting methods, techniques, and evaluation criteria resulting in clinical data of the highest quality

• Implement/innovate new processes for program or assigned studies within a program

• Travel: Up to 25%

Qualifications

• Minimum BA/BS in a relevant scientific discipline

• Minimum 8 years’ clinical trial experience managing Phase 1 through 3 global studies in the oncology pharmaceutical industry

• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCP governing the conduct of routine clinical trials

• Ability to plan, prioritize, and accomplish goals within timelines

• Ability to develop tools and processes that result in increased efficiencies

• Ability to manage responsibilities and resolve complex problems with minimal guidance

• Strong team player and facilitator; ability to incorporate needs from cross-functional areas

• Detail-oriented with meticulous follow-through in a fast-paced environment

• Exceptional oral, written, interpersonal, and presentation skills

• Proficiency using Microsoft Office