Senior Clinical Trial Manager - Mountain View, CA | Biospace
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Senior Clinical Trial Manager

ChemoCentryx, Inc.

Location:
Mountain View, CA
Posted Date:
11/30/2016
Position Type:
Full time
Job Code:
Salary:
$140,000.00
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Cancer, Clinical Data Management, Clinical Project Manager, Clinical Trial Manager, CRA, Drug Safety, Nephrology, Oncology, Pharmacovigilance, Regulatory, Scientist,

Job Description

Senior Clinical Trial Manager Associate Director CTM




Reporting to the Chief Medical Officer, the Senior Clinical Trial Manager will be responsible for the day-to-day management of ChemoCentryx clinical trials, including management of contract CROs conducting company sponsored clinical trials.

Specific Responsibilities:
•   Work with CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines  and budget as needed.
•   Work with CRO to revise scope of service agreements, budgets, plans and detailed
timelines, and ensure that performance expectations are met.
•   Oversee monitoring activities at clinical CROsby reviewing visit reports, protocol deviations and CAPAs; attend co-monitoring visits as required.
•   Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
•   Review and contribute to study Protocols, eCRF design and completion  guidelines, laboratory manuals,Informed Consent Forms, and other study-related  documents.
•   Coordinate/plan investigator meetings and/or site and CRA training.
•      Perform financial management, including review and approval of site and vendor invoices.
•   Track and coordinate trial related materials, including clinical trial supplies and laboratory  samples.
•   Perform review and QC central clinical files and trial master file.
•   Identify potential study issues and recommend and implement solutions or corrective actions as needed.
•   Serve as a liaison and resource for investigational sites; review investigator contracts and site payments.
•   Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
•   Organize and manage internal team meetings and other trial-specific  meetings.
•   Participating in the development, review and implementation of departmental SOPs and processes.

Qualifications:

•      Baccalaureate or Masters degree or equivalent in a scientific or health care field is required.
•    Minimum of 3-5 years of clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance.

•   Experience in managing oncology clinical trials and/or orphan disease indications preferred.
•   Someone with biotech or pharmaceutical experience as an in-house CTM.
•   Someone with CRA experience who has moved into a CTM position.
•   Clinical operations experience at a small or mid-size company.
•   Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
•   In-depth knowledge of clinical research operations, including interpretation and
Implementation of FDA regulations/ICH guidelines, GCP and other applicable regulatory guidelines required.
•   Knowledge of Electronic Data Capture {EDC}.
•      Excellent verbal and written communication skills in order to effectively communicate with site staff, vendors and internal cross functional team members.
•   Strong computer skills including knowledge of Microsoft  Excet Word, and Outlook.
•   Ability to work within established timelines, in a fast paced environment.
•   Excellent organizational and priority management skills.
•   Ability to prioritize and handle multiple tasks at once
•   Travel up to 15-20% may be required.
?   Experience in the U.S. and other countries.
?   Some experience with Pharmacovigilance would be good.







Requirements

BS or Masters degree preferred.
High energy; action oriented
Build effective working relationships
Managing CROs
Travel
Experience in small-mid size biotechs
Experience in running a trial through completion
Strong communication skills