Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

The Associate Director, Clinical Monitoring (AD, CM) is responsible for the day-to-day management of a team of Lead Clinical Research Associates (Lead CRAs) and Clinical Research Associates (CRAs), overseeing their performance and training, ensuring adequate monitoring resources, allocating resources to projects, identifying quality issues related to clinical monitoring activities and establishing action plans to address them.

What You'll Do Here

• Driving the development, revision, and implementation of Clinical Monitoring Standard Operating Procedures (SOPs) and processes
• Managing, developing and expanding Altasciences Clinical Monitoring team and offering
• Supporting business development and sales initiatives
• Provide expertise, strong leadership and management for the planning and execution of monitoring activities across multiple early-phase (Phase 1 and 2) clinical trials.
• Function as a primary Clinical Monitoring management contact for sites, internal teams, and Sponsors.
• Assist in forecasting and managing monitoring budgets and resource allocation.
• Monitor project timelines and deliverables to ensure adherence to contractual obligations.
• Ensure clinical monitoring activities meet Sponsor expectations, by delivering high results on time and within budget, in accordance with applicable SOPs, Good Clinical Practice (GCP), regulations and study-specific requirements.
• Provide quality oversight by managing escalations and identified issues and oversee Corrective Actions/Preventive Actions (CAPAs) to ensure timely and sufficient resolution.
• Track, analyze and follow-up on clinical monitoring metrics.
• Conduct clinical monitoring oversight visits as needed.
• Participate in the preparation, conduct and resolution of audits and inspections.
• Identify and implement professional development plans and conduct performance evaluations.
• Mentor and support other Clinical Monitoring team members.
• Develop, maintain and implement an education and training program on Clinical Monitoring.
• Conduct resourcing and hiring efforts to support team growth and project demands.
• Identify and propose efficient and quality solutions for process improvement opportunities to the Head of Clinical Monitoring.
• Drive the development, revision, and implementation of Clinical Monitoring SOPs, processes and study tools.
• Coordinate team meetings and foster cross-functional collaboration.
• Support sales effort through participation in bid defenses, client meetings and program evaluations.
• Support and promote the continuous growth of the Clinical Monitoring offering.

What You'll Need to Succeed

• Bachelor or higher degree in science related field. Pertinent experience may be considered in lieu.
• A minimum of 10 years of clinically related experience, of which a period of 3 years is preferable in clinical research monitoring or equivalent experience
• Previous CRO experience is preferred.
• Minimum of 2 years in supervision of personnel.
• Strong understanding of clinical trial conduct.
• In-depth knowledge of clinical research industry terminology and practices.
• Solid understanding of ICH-GCP guidelines and applicable global regulations governing clinical research.
• Demonstrated ability to manage, attract, retain, and develop a high-performing team.
• Ability to facilitate team meetings and teleconferences, and foster collaboration across functions.
• Ability to work both independently and within a team environment.
• Strong planning and organizational skills with the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Ability to meet deadlines, multitask, and prioritize based on study needs.
• Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint).
• Ability to learn and train others on required electronic systems.
• Excellent verbal and written communication skills.
• Ability to present effectively to internal teams and external stakeholders.
• Ability to establish and maintain strong working relationships with internal and external customers.
• Client-focused approach with a professional attitude and strong interpersonal skills.
• Solution-focused mindset with the ability to creatively solve problems and resolve issues.
• Proactive and able to take initiative in identifying and addressing challenges.
• Ability to make sound decisions based on available information

Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Associate Director, Clinical Monitoring including, but not limited to, for the following reasons:

• The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.
• The employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices.
• The employee frequently communicates with English-only customers outside the province of Quebec.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

Altasciences' Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Review

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!