CLINICAL ASSOCIATE PROJECT DIRECTOR - Toronto, Canada - Allucent

Description

At AllucentTM, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for an Associate Project Director (APD) to join our A-team (hybrid*/remote). As an Associate Project Director at Allucent, you are responsible for overseeing and managing all aspects of clinical trials from start up through to final delivery for Central Nervous System (CNS) or Cell and Gene Therapy (CGT) trials. This role plays a pivotal part in ensuring the successful execution of trials, from initial planning through to completion, with a focus on safety, regulatory compliance, and efficient project management.

In this role your key tasks will include:

• Strategic Planning: Develop and implement strategic plans for Central Nervous System (CNS) or Cell and Gene Therapy (CGT) trials, including defining project objectives, timelines, and resource allocation.
• Trial Management: Oversee the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Budget and Resource Management: Manage project budgets and allocate resources effectively. Monitor expenses, identify cost-saving opportunities, and report financial progress to stakeholders.
• Team Leadership: Lead and supervise a cross-functional team, including clinical research professionals, project managers, and support staff. Foster a collaborative and motivated work environment.
• Regulatory Compliance: Stay up-to-date with evolving regulatory guidelines and ensure that trials are conducted in compliance with relevant regulations (e.g., FDA, EMA).
• Risk Management: Identify potential risks and develop risk mitigation plans to ensure trial success and patient safety.
• Vendor Management: Select, contract, and manage external vendors and partners, such as Contract Research Organizations (CROs) and laboratories, to support trial activities.
• Data Management: Oversee data collection, analysis, and reporting activities, collaborating with data managers and biostatisticians to ensure data quality and integrity.
• Safety Monitoring: Implement safety monitoring protocols and procedures, ensuring timely reporting of adverse events and appropriate interventions.
• Communication: Maintain effective communication with internal teams, external stakeholders, investigators, and regulatory agencies. Provide regular updates on trial progress.
• Quality Assurance: Implement quality control processes and continuous improvement initiatives to enhance trial quality and efficiency.
• Documentation: Ensure accurate and comprehensive documentation of all trial-related activities, including study protocols, informed consent forms, and regulatory submissions.

Requirements

To be successful you will possess:

• Bachelor's degree in life sciences or a related field (advanced degree preferred).
• Minimum 6 years of relevant work experience.
• Minimum 6 years of experience in drug development and/or clinical research, with at least 4 years of clinical trial project management involving a range of activities related to patient care, treatment administration, data collection, and ensuring the ethical and regulatory aspects of the trial are met.
• Strong knowledge of regulatory requirements and GCP.
• Excellent project management, leadership, and communication skills.
• Ability to analyze complex data and make informed decisions.
• Excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language.
• Representative, outgoing and client focused.
• Ability to work effectively in a fast-paced challenging environment with a growing company.
• Proficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required.
• Strong presentation skills.

Benefits

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

"The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

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