Manager, Clinical Operations

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake. 

When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector. 

We are looking for a highly motivated and experienced Manager, Clinical Operations to join our dynamic team. The successful candidate will be pivotal in managing and overseeing clinical trials, ensuring compliance with regulatory standards, timelines, and budgets, and leveraging their CRA experience for site management and monitoring activities.

This role reports to the Director, Clinical and Regulatory Affairs and is integral to our clinical and regulatory activities. Responsibilities include designing and implementing CRO service offerings to support the organizations growth and our client engagements.

Key Responsibilities, include but are not limited to:

Clinical Operations:

• Design and implement comprehensive CRO service offerings, including clinical trial management, data management, regulatory affairs, and quality assurance.

• Collaborate with leadership to create strategic plans and roadmaps for API’s CRO services, aligning with organizational goals and industry standards.

• Build cross-functional teams of experienced professionals to deliver high-quality CRO services.

• Develop standardized processes, procedures, and workflows for efficient project execution, ensuring adherence to timelines, budgets, and regulatory requirements.

• Establish relationships with key representatives of pharmaceutical & biotech companies, academic institutions, and regulatory authorities, to promote CRO services and secure partnerships.

• Provide leadership, mentorship, and training to team members, fostering a collaborative and innovative work environment focused on delivering excellence in CRO services.

Project Management:

• Lead and manage all aspects of clinical trials from start-up to closeout.

• Develop and execute project plans, timelines, and budgets in collaboration with cross-functional teams.

• Monitor trial progress, identify risks, and implement corrective actions as needed to ensure successful trial execution.

Regulatory Compliance:

• Ensure compliance with applicable regulatory requirements, ICH-GCP guidelines, and company SOPs.

• In collaboration with the Clinical & Regulatory Affairs team, prepare and submit regulatory documents, including study protocols, investigator brochures, and ethics committee submissions.

Vendor Management:

• Oversee relationships with external vendors, central laboratories, and other third-party providers.

• Manage vendor contracts, budgets, and performance metrics to ensure quality and cost-effective services.

Data Management:

• Coordinate data collection, review, and analysis activities to ensure data integrity and accuracy.

Risk Management:

• Identify potential risks and develop risk mitigation strategies to minimize impact on clinical trial outcomes.

• Conduct risk assessments and implement risk management plans as necessary.

Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)

Education

• Bachelor’s degree in health sciences, Life Sciences or Nursing specialty preferred. SoCRA and/or ACRP Certification/Designation is an asset.

Experience:

• Minimum of 4 years of experience leading clinical operations in roles such as Clinical Operations Leader, Clinical Trial Manager, or Clinical Project Manager within a Contract/Academic Research Organization, biotechnology, or pharmaceutical company. Prior experience as a Clinical Research Associate is preferred.

• Clinical Operations Expertise: Demonstrated strong experience and understanding of clinical trial operations, including study protocols, site management, monitoring activities, and regulatory compliance.

• Project Management Skills: Ability to plan, organize, and manage clinical trial projects from initiation to closeout, ensuring adherence to timelines, budgets, and quality standards.

• Proven track record of implementing, supporting, and utilizing Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).

Personal Competencies

• Regulatory expertise: Knowledgeable about GCP, ICH guidelines, and local regulations.

• Effective communication: Skilled in collaborating with internal teams, vendors, sites, and regulators.

• Problem-solving skills: Analytical approach to handling trial challenges such as protocol deviations, data discrepancies, and site issues.

• Detail-oriented: Ensures data accuracy and protocol adherence.

• Adaptability: Capable of navigating dynamic environments and making informed decisions.

• Ethical commitment: Ensures compliance with regulations and prioritizes participant safety.

Working Conditions:

• Required travel between Edmonton API sites.

Additional Required Documents to Support Application

• Applications submitted without a resume & cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API, we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered, ensuring that you and your dependents receive the necessary healthcare support.

Payment in Lieu of Pension: API provides an additional 15% of your annual base salary, as an alternative to traditional pension benefits.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities, including training programs, workshops, conferences, and certifications. We encourage employees to enhance their skills, broaden their knowledge, and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API, we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork, open communication, and a supportive atmosphere where everyone's contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program, which promotes the use of environmentally friendly modes of transportation. By participating in the program, you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking, biking, carpooling, and public transportation.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants' interest but will only contact those selected for interviews.

If you have any questions about the job posting, please email careers@appliedpharma.ca.

Our team, clients, and stakeholders come from a variety of backgrounds. In recruiting for our team, we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences, education, culture, gender, race, sexual orientation, religious or ethnic background, neurodiversity, and cognitive and physical ability.