Director of Clinical Research Operations

Director of Clinical Research Operations

May 16, 2022 By

Introduction:

Reporting to the CEO with a dotted line to the Principal Investigator (PI), the Director of Clinical Research Operations performs a key leadership role within the organization. The Director works collaboratively with the executive to establish and guide research priorities, and assess organizational needs and processes associated with clinical research. In this position the Director, in collaboration with the PI, will be responsible for efficiently and effectively managing the day-to-day operations of clinical research through the effective management of a qualified research team. The Director effects oversight, development and prioritization of clinical trial projects through direct interactions with the senior leadership team, upholding best practices and ensuring adherence to industry regulations and Standard Operating Procedures (SOPs) and ensuring the senior leadership team are kept up to speed and current on all emerging issues and concerns. The Director is responsible for assisting in developing and putting forth a business case for the overall clinical research site as well as on a per-trial basis in collaboration with the senior management, inclusive of budget management. With the assistance of the Director of Finance, the Director of Clinical Research Operations develops a budget for the Clinical Research function and ensures the team adheres to the budget as set out.

Let’s build a better world together. Apply now!

Why join us

Best workplace
We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.

Best people
We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.

Best opportunities
We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients.

Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!

Job Responsibilities:

  • Bachelor’s degree in a scientific discipline or health professional degree or recognized equivalent; Master’s degree preferred.
  • Recognized certification (e.g., ACRP or SOCRA) and post-graduate certificate in clinical research is considered an asset.
  • Minimum 5 years supervisory/management experience managing project teams carrying out clinical trials.
  • Minimum of 5 years of true clinical research operations (CRO) experience culminating in exceptional operational oversight.
  • Minimum 10 years of experience working in a clinical trials environment culminating in a thorough understanding of the relevance of clinical processes, data management, biostatistics and medical writing.
  • Excellent working knowledge of industry compliance standards including ethics, governmental regulations and expectations, GCP and ICH guidelines, and best practices in addition to the application of each to the conduct of clinical trials.
  • Proven ability to think strategically and to develop clear action plans to align with and ensure delivery of the organization’s strategy and goals and clinical development plans.
  • Proven ability to manage relationships and communication with vendors, review and monitor study performance/metrics, and plan, implement and execute projects.
  • Demonstrated strong management, leadership and motivational skills.
  • Excellent analytical and problem-solving skills (recognizing, analyzing and resolving).
  • Excellent and effective interpersonal and communication skills, both verbal and written.
  • Excellent decision-making skills with the ability to form/defend/articulate independent judgments in assessing difficult situations.
  • Excellent organizational and time management skills to work effectively and efficiently while demonstrating composure under pressure/stressful conditions to meet multiple, concurrent and competing deadlines and priorities.
  • Ability to adapt to and implement change effectively and facilitate its acceptance by others.
  • Working knowledge of Microsoft Office including Word, Excel and PowerPoint.
  • Knowledge of EDC (electronic data capture) platforms used in clinical trial data management.
  • Ability to work cooperatively in a team environment.
  • Attention to detail is imperative.
  • Displays the highest degree of integrity.

In addition to the skills and qualifications above, we value the following qualities in all of our team members:

  • High-quality standards, responsibility, and engagement.
  • Ability to interact with a range of personalities and many levels of the organization.
  • Demonstrated self-motivation and the ability to take initiative.
  • Project management and strong prioritization skills.
  • Attention to and ability to execute details.
  • Adaptable to changing environment, client, and project needs.

Job Type: Full-time 

Location: Ontario, Canada.

Benefits Include:

  • Disability insurance
  • Dental Care
  • Extended health care
  • Life insurance
  • Vision care
  • Wellness program
  • Work remotely/optional

Applying:

To be considered for future opportunities, please email your cover letter, resume/CV, and any related supporting documentation to hr@dicentra.com with “Director of Clinical Research Operations” in the subject line.

As part of the hiring process, in addition to interviewing, successful candidates may be required to complete a skills assessment and a reference/background check. If you are sent a skills assessment, please complete it for consideration for the advertised position.

We thank all applicants for their interest, however, only those selected for an interview will be contacted.