Manager, Research Operations

LMC Diabetes & Endocrinology - Greater Toronto Area, ON (30+ days ago)

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LMC Diabetes & Endocrinology is Canada’s largest specialty provider in Diabetes and Endocrinology. We have over 50 Endocrinologists and 34 Diabetes Educators in 11 centres of excellence providing specialist care to over 56,000 patients across Canada.

In 2015, Manna Research and LMC Diabetes & Endocrinology (LMC) merged their research operations creating one of the largest networks of fully-owned and integrated outpatient clinical research sites in North America. Combined, they have over 40 years of experience conducting more than 1500 clinical research studies to thoroughly test new medications or medical devices for safety and efficacy. Manna Research has 7 locations across Canada.

Currently, our rapidly expanding team is in need of a Manager, Research Operations who can work for us on a full time basis with travel to various sites.

The Manager, Research Operations is responsible in ensuring that the organization’s clinical research personnel conduct trials in compliance with established policies, SOPs, ICH/GCP, regulatory and protocol requirements. The Manager, Research Operations is also responsible for supporting key strategic objectives as it relates to quality, recruitment or retention by direct support to the Site Leads/Managers.

Responsibilities include but are not limited to:
Ensure the safety and welfare of study participants

Knowledgeable of and remain current with all clinical trial protocols, LMC Research SOPs, regulatory guidelines and principles of ICH/GCP

Ensure Regional Site Leads/Managers adequately train study staff on conducting clinical research studies according to the clinical trial protocol, LMC Research SOPs, regulatory guidelines and principles of ICH/GCP

Create and maintain job descriptions and ensure sites have adequate resources

Ensure there is an appropriate training and onboarding program in place and requirements are fulfilled for Clinical Research Staff, including Clinical Research Coordinators, Investigators and all Clinical Research Personnel

Support Manager, Patient Engagement in initiating recruitment plans for upcoming studies to ensure all objectives are met prior to the first patient visit and to provide metrics to Sponsors

Support implementation of retention strategies at the sites

Work with Manager, Quality Assurance to understand risks at sites and support corrective and preventative action plans

Assist the President, Research on items that may support business development, study start up and close out of studies.

Support integration of new Manna and/or LMC Sites

Liaise with CRA's and Project Managers related to CRC/Lab Tech monitoring and potential new research opportunities for LMC

Assist with audit preparation for various site inspections which include but are not limited to FDA, HC or Sponsor audits

Assist in maintaining, updating and implementing biennial Research SOPs or required edits

Coordinate quarterly check-ins and annual reviews for all Regional Site Leads and Site Managers

Organize "team" building events and educational workshops for Research staff

Lead weekly research meetings with Regional Site Leads / Managers and bi-monthly CRC teleconferences

Attend Town Hall meetings as needed to represent Research

Actively network with industry related contacts and organizations to help with promotion of LMC|Manna research

Willing to travel and support all LMC sites in Ontario, Quebec, BC and Alberta

Qualifications- Education, Experience & Certification :
Bachelors of Science Degree or equivalent, required

Post secondary education in a clinical research program (preferred)

ACRP certified Clinical Research Coordinator or equivalent

A minimum of 3 years of Clinical Research experience

Project Management experience, preferred

LMC |Manna provides six industry-leading programs:
Endocrinology Specialist Practice (publicly-funded) - representing the largest non-academic group of Endocrinologists globally

Nationally-accredited Diabetes Education Program (publicly-funded)

A network of diabetes focused pharmacies

Chiropody & Foot Care Specialist Care (New)

Optometry & Eye Care Specialist Care (Coming Soon)

Canada's largest Clinical Research network specializing in Diabetes innovations

Why LMC|Manna might be right for you!

2016 Certified Best Workplace™

2014 and 2015 Canada’s Best Workplaces™

Competitive Salary

Comprehensive Health Benefits

RRSP contribution matching

Education allowance (days and funding)

Ongoing career training and development

Employee Appreciation Days Off

Additional Holiday Closure

Opportunities to work with internationally renowned Endocrinologists

State of the art Electronic Medical Records (EMR) environment

LMC|Manna is committed to meet the accessibility needs of persons with disabilities in a timely manner. These accommodations will be available upon request.

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