Location:
Waltham, MA
Posted Date:
4/9/2012
Position Type:
FULL
Job Code:
CPMB11
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Description
About AKP America
Asahi Kasei Pharma America (AKP America), formerly Artisan Pharma, is a biopharmaceutical company dedicated to bringing best-in-class critical care therapeutics to patients throughout the world. The company is a wholly-owned subsidiary of Asahi Kasei Phama, Corp.
ART 123(recombinant human thrombomodulin alpha, marketed as Recomodulin® in Japan), our lead product candidate, represents a promising new treatment for severe sepsis with coagulopathy. This drug has successfully completed a Phase 2b clinical trial in disseminated intravascular coagulation (DIC) and Phase 3 trials will be underway shortly. This product might also be beneficial for a number of other indications.
Under the direct supervision and assistance from the Global Project Manager and/or the VP Clinical Operations, the Clinical Project Manager is accountable for the day-to-day operations in a defined geographic region of one or more clinical trials commensurate with complexity, including trial start-up, conduct, monitoring, and close-out activities. This position will develop and implement initiatives aimed to ensure the successful and timely completion of the ART 123 clinical trials and all related clinical trial milestones.
Provide input on the clinical study design, monitor trial progress, manage the project level budget and oversee quality assurance, managing external vendors, data management, and ensuring that reporting activities are completed.
Direct site communication and clinical monitoring input related to product development
Oversee vendor training and performance for all clinical aspects of drug development
Coordinate materials for clinical trials
Validate site-specific regulatory documents for IND and BLA filing
Track tasks performed by CRAs and other project staff
Monitor vendor GCP audits
Review all clinical documents
The CPM will have responsibility for reviewing, and creating Clinical Monitoring SOPs, managing training, and providing a leadership role in the maintenance of Clinical Operations Monitoring standards
Oversee project teams to achieve efficient and effective performance
Deliver projects/programs on time and budget
Maintain a positive, results-oriented work environment, build partnerships and a positive team-based culture
Communicate with organization in a clear, open, balanced and objective manner
Requirements
A minimum of 5 years clinical trials experience required
Bachelors degree in a scientific or health-related field, R.N. preferred
Broad experience with all aspects of clinical monitoring and oversight of contracted resources
Fundamental knowledge of GCP, FDA and ICH regulations.
The CPM candidate will have at least 2 years experience leading trials and at least 5 years of clinical research experience in the biotech, pharmaceutical, or contract research organization arena, and of which at least 3 years experience as a Clinical Research Associate (CRA).
Therapeutic knowledge in any of the following areas is desired: Sepsis, critical care, oncology, respiratory/pulmonary, or anti-infectives
Applicants must be highly self-motivated, with superior organizational, communication, and management skills. Travel domestic and international as much as 30% during the interim phase of the trials
Experience in budget preparation and financial management
Ability to mentor as well as build network and strategic partnerships
Skilled at developing and implementing creative solutions
Ability to work constructively and productively in a matrix environment, willingness to hold direct reports accountability
Sense of urgency, accountability for self and sound operational understanding
Asahi Kasei Pharma America (AKP America)is actively hiring new employees in the Boston area to support its product development efforts for ART-123. AKP America offers a competitive salary and benefits, a stimulating environment that values teamwork, and the opportunity and expectation for individual excellence.
To apply for one of these positions, please visit http://ak-america.iapplicants.com to access our online application process.
Asahi Kasei Pharma America Corporation is an Equal Opportunity Employer. Pre-employment background check and drug testing required.
Agency Notice
Asahi Kasei Pharma America (AKP America) does not accept unsolicited resumes from any third-party recruiters, agencies or individuals. Any such third party recruiters, agencies or individuals seeking to work with AKP America must first contact the staffing group at careers@akpamerica.com. Only approved staffing vendors will be allowed to provide services to AKP America. Unsolicited resumes will be deemed the property of AKP America to follow up with as it sees applicable and no fee will be paid in the event the candidate is hired as a result of the referral or by other means. Submission of unsolicited resumes does not create any implied obligation on the part of AKP America.
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