Senior Clinical Trial Manager - South San Francisco, CA | Biospace
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Senior Clinical Trial Manager

Portola Pharmaceuticals, Inc.

Location:
South San Francisco, CA
Posted Date:
8/18/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Trial, Clinical Trial Manager,

Job Description


Portola Pharmaceuticals is a biopharmaceutical company, headquarted in South San Francisco. Developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the U.S. Food and Drug Administration in June 2017. The company is also working to advance two clinical programs for AndexXa® (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a SYK/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective SYK inhibitors for inflammatory conditions. These wholly owned compounds come from our own internal research efforts and represent important advances to address significant unmet needs.

The Senior Clinical Trial Manager will be responsible for the operational management and oversight of clinical trials within a clinical development program; the level of independence and scope of responsibilities assigned may vary depending on the experience of the successful candidate. The successful candidate will work closely with the Medical Monitor and other cross-functional representatives, including Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology, Biology, etc. to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. The Senior CTM will also provide oversight of the CRO and other third party vendors on assigned study. This is an in-house position.

Responsibilities:

• Manage and oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Director or CRO as appropriate
• Perform clinical data review of data listings and summary tables, including query generation
• Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
• Develop and maintain good working relationships with investigators and study staff
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
• Track and report on progress of study including site activation, patient enrollment, monitoring visits
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience)
• Investigate queries, monitor discrepancies
• Manage investigational product (IP) accountability and reconciliation process
• Responsible for review or approval of IP release packages
• Negotiate and manage the budget and payments for investigative sites, if applicable
• Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
• Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
• Develop CRA and third party vendor training on protocols and practices
• Identification and hiring of appropriate CROs and third party study vendors
• Other duties as assigned

Requirements


• Bachelor’s degree or equivalent with 8-10 years’ Clinical Operations work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process
• Clinical trial management experience from protocol development through final study report experience
• Global Phase III experience in cardiovascular or oncology drug development desirable
• Cross-functional team leadership experience required
• Management of international clinical studies preferred
• Cardiovascular and/or oncology study experience preferred
• Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting, etc.)
• Previous experience working with an electronic data capture system and CTMS system required
• Proficient with MS Word, Excel and PowerPoint. Experience with MS Access and MS Project a plus
• Strong interpersonal, communication (written and verbal), and organizational skills
• Demonstrated ability to work independently as well as part of a multi-functional study team
• Able to motivate a team to work effectively under a changing environment
• Able to solve problems under pressure
• Self-motivated and able to work effectively in a matrix/team environment
• Availability for potential travel domestically and internationally

Additional Information:

• Our company overview and history: http://www.portola.com/Company-Overview
• Please include a resume and cover letter that highlight your qualifications and matches our requirements.