Company: Wild Tusker Technologies & Business Solutions Inc
Position Title: Life Sciences Project Manager
Term of work: Full time permanent
Salary range: $34-40 / hour
Location: Vancouver, BC
We’re a small-size Technology Solutions provider and Contract Research Organization (CRO) that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers, and hard workers and, together, we are changing the way the world experiences CROs, in the best possible way.
The Life Sciences Project Manager is responsible for managing key client relationships and overseeing a program of studies/projects for a specific client, providing Life Sciences and pharmacovigilance leadership, management and expertise to staff working on projects within the program. Focus on providing proactive management across a portfolio of studies to ensure continuity and consistency in communication and case processing.
Tasks may include but are not limited to:
• Serve as primary point of contact with client as well as internal team to ensure consistency, compliance, and quality across projects
• Oversee the management, monitoring, adjustment, and ongoing revision of safety management plans (updates to plans, review of risks and identification of new mitigation strategies)
• Provide periodic management level QC of cases to ensure consistency, quality, and compliance in case processing
• Maintain and QC PV section of TMF
• Track and monitor PV status for each project
• Generate and provide status reports including line listings and metrics to monitor compliance, progress, and quality
• Manage deliverables across the PV and clinical team
• Manage change orders and out of scopes
• Monitor progress and provide oversight and alignment across PV team for consistency, compliance, quality
• Represent PV at key client meetings
• Responsible for liaising and collaborating with other worldwide clinical project departments working with the same client.
• May serve in a line manager capacity with direct reports depending on business needs
o Provide direct supervision of assigned staff and projects including:
All pharmacovigilance activities are performed according to applicable regulations and processes
Work is performed according to the budgeted scope of work
Work is performed within applicable timelines and according to applicable quality standards
o Provide guidance and coaching to direct reports
• Escalate any issues or concerns related to study or staff conduct
• Maintain knowledge and understanding of safety related regulations and guidelines
• Maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
• May participate in proposal review and budget process, bid defense meetings, authoring department standard operating procedures
• Organize and provide training sessions
• Participate in staff recruitment and on-boarding
• May represent PV at sponsor audits as needed
• Participate in department and company-wide initiatives as needed
• May serve as back-up to senior PV leadership as needed
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Other Skills and Abilities:
• Excellent leadership skills and ability to build and manage the teams.
• Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements.
• Excellent skills and hands on experience of computer technology, and management of relational database systems, including extraction of data.
• Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment.
• Excellent organization skills and ability to handle multiple competing priorities within tight timelines
• Consistently demonstrates commitment, dependability, cooperation, adaptability, and flexibility in executing daily tasks and responsibilities.
• Ability to anticipate needs and follow through on all assigned tasks
• Able to effectively receive and provide constructive feedback without becoming defensive.
• Able to work well independently, but also able to seek input effectively from others when appropriate. Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame.
• Master’s degree in a Pharmacology and/or Medical biology/Epidemiology or other relevant fields.
• Minimum 5 years of global pharmacovigilance experience with safety database and a variety of study phases in various therapeutic areas
• Demonstrated history of strong leadership skills including a minimum of 4 years in a mentorship capacity. Scientific and medical writing experience is required.
• Experience in working multiple therapeutic areas. Oncology therapeutic area experience is an added advantage.
• Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word).
• Excellent written and verbal communication skills
• Excellent organization skills and attention to detail
• Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines.
• Ability to work independently, prioritize work effectively and work successfully in matrix team environment
• Proven experience in creating SOPs, reporting requirements and accepted practices
• Good understanding of the work performed by other functions and how they interact
• Understanding of and appreciation of the wider issues affecting the efficiency and running of the department
• Proven ability for working independently with minimal supervision
• Proven experience of good interpersonal and communication skills when dealing with Sponsors, supporting colleagues, and making presentations
• Confidence in dealing with external and internal clients and providers
• Ability to motivate other team members to achieve project and personal targets
• Ability and willingness to travel domestically and internationally if needed to support project meetings, bid defenses, and/or provide support for business development efforts
Please email your CV or any questions to firstname.lastname@example.org. We thank all applicants for their interest, however only those candidates who are eligible to work legally in Canada and selected for interviews will be contacted.
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