Clinical Program Manager

Location
Redwood City, CA, United States
Posted
Sep 01, 2020
Ref
537089690
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Clinical Program Manager

We are looking for a Clinical Program Manager to implement and oversee phase 1-3 investigational drug trials that are conducted primarily in the United States, and to ensure quality of the trials.

Top candidates are proficient multitaskers, have the ability to prioritize tasks, and can work successfully in a start-up environment.

This position reports to the Vice President of Clinical Operations.

Clinical Program Manager Responsibilities:
  • Develop the protocol, protocol amendments and informed consent templates with the assistance of other Allakos team members
  • Create case report forms with the assistance of the Allakos Data Management team
  • Oversee and coordinate activities from site start-up through closeout
  • Perform and oversee activities to ensure timely study enrollment
  • Assist with data review and cleaning
  • Provide study monitors with protocol-specific training and having regular meetings with them
  • Oversee the monitoring of sites by study monitors
  • Coordinate monitoring activities for data sweeps and/or data base lock
  • Report the progress of the studies to Allakos management on a regular basis
  • Direct Clinical Trials Assistants as needed
  • Oversee CROs responsible for monitoring study sites outside of the United States
  • Oversee the gathering and examining of trial documents for the Trial Master File
  • Oversee the activities of study vendors such as the central clinical laboratory, bioanalytical laboratory, and EDC vendor
  • Respond to questions from IRBs/ECs and study vendors
  • Respond to questions from the study sites regarding the protocol and study procedures
  • Trouble-shoot study-related issues occurring at the site or with vendors
  • Assist with the writing of the Clinical Study report as needed
  • Assure compliance with SOPs and local regulations, and CFR, ICH and GCP guidelines.

Clinical Program Manager Requirements:
  • 3 or more years of experience monitoring drug studies at study sites and working closely with study coordinators
  • Experience managing one or more studies preferably from study start-up through database lock
  • Experience reviewing large sets of clinical data and/or prior experience with data management a plus but not necessary
  • Excellent communication skills, both verbal and written
  • Proficient with Microsoft Office Word and Excel
  • Understanding of Electronic Data Capture (EDC)
  • Bachelor's degree in nursing or life sciences or relevant experience
  • Ability to work remotely at home. This is a home-based position that can be located anywhere in the United States.
  • Availability to travel for clinical team meetings at company headquarters in California, Investigator Meetings and/or to visit study sites if needed.
  • Valid driver's license.


Allakos is based in Redwood City, CA, this role can be located anywhere in the US

The salary is competitive and commensurate with experience and qualifications.

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.