Jobs in Markham, Canada

Remote, United Kingdom

Precision for Medicine is growing! We are hiring Manager, Clinical Monitoring to join our European team. The position could be covered fully remotely from the UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.

Position Summary:

• The Manager Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities are focused on the management and career development of the organization’s Clinical Research Associate (CRA) workforce as well as supporting the development of departmental initiatives to strengthen the quality and productivity of GCM operations.
• This position requires the ability to independently lead, manage, and motivate a team of CRAs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful. In addition, this position will provide the CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction

Essential functions of the job include but are not limited to:

• Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.
• Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams.
• Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
• Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.
• Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.
• Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
• Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
• Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
• Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution.
• Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.
• Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process.
• Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas.
• Represent Precision for Medicine in a professional manner
• Manage CRA staff in accordance with Precision for Medicine’s values and policies.
• Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.
• Perform other duties as assigned by Leadership

Qualifications:

• Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline.
• Fluent in English and French
• At least 7 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.
• Strong monitoring experience in oncological clinical trials.
• 3-5 years of direct supervisory experience managing CRAs is expected in candidates for this position including:

o Experience creating effective development programs for clinical staff.

o Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards

• Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.

Skills and Competencies:

• Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.
• High capacity for Emotional Intelligence and a passion for people management and development.
• As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs
• Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level.
• Demonstrates understanding and ability to work with EMRs and EDCs
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Motivates other members of the project team to meet timelines and project goals.
• Highly organized, ability to set priorities and possesses excellent problem-solving skills.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.

#LI-TB1

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to ourCA Privacy Notice .

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

*

indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School Select...

Degree Select...

Select...

Start date year

LinkedIn Profile

What is your desired salary? *

Are you authorized to work lawfully in the country/location for which you are applying? * Select...

Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status. * Select...

Have you ever worked for Precision Medicine Group or one of its affiliated companies? * Select...

If yes, when and which company?

Have you ever interviewed with Precision Medicine Group or an affiliated company? * Select...

If yes, when and which company?

Are you currently subject to a Non-Compete or Non-Solicit with your current employer? * Select...

I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge. If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment. I authorize the Company or its agents to confirm all statements contained in this application and/or curriculum vitae as it relates to the position I am seeking and to the extent permitted by the laws of the country where the job is located (“Applicable Laws”). I agree to complete any required authorization forms for the background investigation. I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by Applicable Laws, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information. If hired, I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the country where the job is located. I also understand that the Company employs only individuals who are legally eligible to work in the country where the job is located. * Select...

Legal Address - Street Address 1 *

Legal Address - Street Address 2

Legal Address - City *

Legal Address - State * Select...

Legal Address - Zip *

Legal Address - Country * Select...

How many years of CRA Line Management experience do you have? *

How many years of monitoring experience related to oncological clinical trials do you have? *

Are you fluent in English and French languages? *