Delivery Manager (Clinical Trial Management)

Description:

Actalent is currently hiring for a Delivery Manager - Clinical Trial Management role. This is a permanent leadership position. Here are some key details about the role:

• The role will support day-to-day management of both short- and long-term department and client projects from start to finish in alignment with company clinical operations strategic goals and initiatives. This position will support the Global Head, Clinical Practice to manage successful delivery of multiple, high-impact reporting and process improvement initiatives, as well as providing project management expertise

• The DM CTM may support Business Development in assessing opportunities including solutioning and assisting in proposal documents for new projects; the DM CTM may also be responsible for direct client/customer management including business retention and maintenance

• Lead clinical operations activities for assigned employees and or programs ensuring compliance with GCP, ICH and applicable regulations; may lead the development of all study related plans necessary for trial conduct

• Develop project timelines to meet department and corporate goals for timely initiation and completion of assigned clinical studies

• Managed resources (e.g., Managers, CPM, CRA, CTA, etc.) to support assigned projects; the DM may be required to support projects directly for some client, dependent on corporate goals and project requirements

• Identify study risks and develop and implement mitigation strategies for clinical studies; collaborate with Client Study Management Team and QA Team to identify potential risks

• Partner with and ensure regular and effective communication with key stakeholders

• Oversee and track vendor performance metrics for assigned trials, as applicable

• Provide Sr Management with timely updates on progress, changes in scope and schedule

• Coordinate enrollment efforts for assigned programs/studies, as applicable

• Work with client staff to develop and revise scope of service agreements, as applicable

• Review investigator contracts and site payments and approval of site and vendor invoices, as applicable

• Contribute to study protocol, clinical study reports, sections for investigator's brochures and other regulatory documents, as required

• Ensure clinical trial master file for assigned trials are being updated by vendor and are inspection ready, as applicable

• Location: Toronto, ON or USA; other locations may be considered

Additional Skills & Qualifications

• At a minimum, completion of a undergraduate degree (e.g. Life Science, Data Science, Nursing, Medicine, etc.) is required. Advance degree is strongly preferred

• A minimum of 10 year of related job experience is required for this position

• Strong knowledge of clinical operations and project management, including on-site monitoring and site management is required

• Strong knowledge and experience in multiple EDC and CTMS systems, ICH-GCP guidelines and RBM best practices; strong working knowledge of risk management and data management

• Experience within the pharmaceutical and medical device industry and expert knowledge of FDA and EU regulatory requirements is a must. Knowledge of additional regulatory bodies is a very strong asset

• Strong computer skills in appropriate software applications and related systems required.

• Experience in multiple therapeutic areas is strongly preferred; experience in the following areas oncology, CNS, pain, CV, immunology, orthopedics, surgery, metabolic is an asset

• Must have strong written and oral communication skills and Experience mentoring/coaching and providing training is preferred

• Must have the ability to work with a set of predefined risks and adapt to new protocol-specific risks is required

• Must have the ability to collaborate with all levels of management in a cross-functional team environment is required

• Ability to travel to support client and company meetings is a must (up to 20%); for domestic, trans-border and international

REFCR2023

Pay and Benefits

The pay range for this position is $100000.00 - $150000.00

The benefits for the role of Delivery Manager is below:
• Paid Time Off
• Six paid holidays
• M/D/V Benefits

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $100,000 - $150,000