Clinical Program Manager/AD

Advanced Clinical

Posted: January 15, 2016

Job ID: 139

Job Summary

Term: Full-Time
Job Roles: Other
Therapeutic Experience: Oncology
Required Education: Minimum BA/BS
Required Experience: 4+ years
Compensation: salary

Job Description

Hi,
Hope you are doing well. Please review the job opportunity below and contact me if you are interested or may know of someone interested.
Thank you in advance.

Advanced Clinical is a global, clinical outsourcing organization built around delivering a truly better clinical trial experience. We have a great job opportunity for a Clinical Program Manager/Associate Director to work within one of our Oncology Sponsors in Pleasanton, CA:

The Clinical Program Manager will be responsible for overseeing all aspects of the clinical program. This role will partner with the Clinical Operations staff and other departments to ensure that 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 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

Please let me know your salary requirements, we can discuss it once we connect. They would like to stay at 155K if possible.

Please email me your resume/CV to mouranos@advancedclinical.com and let me know when you have time to discuss the position over the phone.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.
Thank you,

Mohammad Ouranos| Clinical Recruiter
Advanced Clinical
570 Pacific Ave, San Francisco, CA 94133
M 949-836-3439
mouranos@advancedclinical.com
www.linkedin.com/in/mohammadouranos/
www.advancedclinical.com

Be Advanced. Advanced solutions for a better clinical experience.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.

Look up active jobs on our website & email me the job order # directly! http://www.advancedclinical.com/find-a-job