Clinical Project Manager

TERMS OF EMPLOYMENT

This is a full-time position (1.0 FTE)

COMPANY PROFILE

Qu Biologics is a private, clinical-stage biopharmaceutical company located in Vancouver, BC, that develops Site Specific Immunomodulators (SSIs) which are designed to restore the body’s normal immune function to reverse the chronic inflammation underlying many conditions including cancer and inflammatory bowel diseases (IBD).

IS QU FOR YOU?

Love doing something that you can feel passionate about? Excited by innovation? Love new ideas and working with a creative, fun and inspired team? Want to make a difference in the world and work with people who feel the same? Then this is for you!

  • You are innovative, practical and enjoy finding the most efficient and cost-effective solutions to real-world problems
  • You understand the importance of identifying and overcoming rate-limiting steps to ensure that projects are moving forward as quickly as possible, without sacrificing quality
  • You value respectful, open communication and inspired teamwork to achieve shared goals
  • You are well-organized, understand the importance of detail, and able to multi-task and prioritize duties effectively
  • You always ask “Why?”

Take a look at our core values and meet the Qu team in this video where Qu’s Research Operations Manager, Momir Bosiljcic, takes you on a tour of Qu Biologics!

POSITION DESCRIPTION

This job posting is for a full-time (1.0 FTE) position that reports to the VP, Clinical Operations & Drug Development.

The Clinical Project Manager will work closely with cross-functional representatives in-house, as well as contract research organizations (CROs) and other third party vendors as necessary, to ensure successful completion of all clinical activities/project deliverables within the established budget and timelines. Responsibilities will include assisting in the execution of clinical protocols within a clinical development program, directly managing study sites or managing CROs who may manage study sites, having responsibility for the preparation of IRB/REB documents and the maintenance and creation of clinical operations SOPs. Support will be provided to the writing of study protocols, statistical analysis plans (SAPs) and clinical study reports.

The successful candidate must be a results-oriented “do-er” who is happy to roll up their sleeves and do whatever it takes to get the job done.  This position requires someone organized, detail oriented and able to work independently as well as part of a team. Get ready to join a demanding, high-performance team functioning in an exciting, fast-paced, clinical environment!

Specific duties and responsibilities will include:

Site Monitoring & Compliance

  • Assist in the oversight of CROs and third party vendors, including co-monitoring, to ensure compliance with study protocol
  • Prepare IRB/REB documents
  • Responsible for project start-up activities including but not limited to: site feasibility, site selection/recommendation, and regulatory preparation in conjunction with relevant departments
  • Monitor performance of investigational sites; prepare or review visit reports
  • Ensure studies are carried out according to the study protocol, applicable SOPs, ICH/GCP regulations and study-specific manuals and procedures
  • Track and report on study progress and key study metrics

Data & Material Management

  • Review and approve the data management (EDC) system, study manuals, study plans and other study related materials
  • Perform clinical data review of data listings and summary tables; generate queries as necessary
  • Oversee discrepancy management, ensure queries are appropriate and responses are timely
  • Manage study drug accountability, shipments, reconciliation and return process
  • Provides site, CRO and vendor training on new or amended protocols and other study materials as appropriate
  • Review invoices from sites, CROs and third party vendors to ensure work has been completed satisfactorily prior to payment
  • Provide support in the development of clinical protocols, SAPs, consent forms, and other program/study related documents

Relationship Management

  • Manages relationships and establishes strong partnerships with CROs, vendors, investigators and other external partners
  • Works as part of the Clinical Operations team in the selection of CROs and other third party vendors
  • Member of cross-functional clinical trial teams (internal and external) representing Clinical Operations

Additional duties/responsibilities

  • Monitoring of clinical investigational sites as required. (Travel when necessary)
  • Ability to write/edit clinical study documents in a coherent and complete manner
  • Other duties as assigned
QUALIFICATIONS

Post-secondary education or equivalent training & experience in clinical, science, or health-related field from an accredited institution

Five or more years of clinical research experience, including at least two (2) years clinical trial management

Familiar with routine medical/scientific terminology

Knowledge of ICH guidelines and GCPs governing the conduct of clinical trials

  • Knowledge of Health Canada / FDA and/or EMA Regulations
  • Highly effective verbal and written communication skills in English
  • Performs job duties independently with minimal supervision and guidance
  • Self-motivated and displays initiative
  • Effectively collaborates with team members
  • Proven organizational skills demonstrated by the ability to understand and prioritize instructions and deliver on time
  • Experience using computer applications including spreadsheets, email, word-processing software & web-based systems
  • Attention to detail
LANGUAGE REQUIREMENTS

Fluent English

DESIRED START DATE

June 2017

COMPENSATION

Salary commensurate with experience. A healthcare spending account and share options are available. Three (3) weeks annual vacation.

COMPANY

Qu Biologics Inc.

CRA 842333817

BUSINESS ADDRESS & LOCATION OF WORK

887 Great Northern Way, Suite 138

Vancouver, British Columbia V5T 4T5 Canada

HOW TO APPLY

If this opportunity matches your character, experience and skill set, please email a cover letter and your curriculum vitae in pdf format to the attention of Mr. Jim Pankovich, VP, Clinical Operations and Drug Development at jobs@qubiologics.com. Applications may also be sent by regular mail to the Business Address provided above. Applications will not be accepted by fax or over the phone.

We thank all applicants for their interest in this position. We regret that only those selected for an interview will be contacted. Please note that we will not be fielding inquires by phone.

Past events:


Past events: