Manager, Clinical Monitoring
Your New Company!
At reputed company we reputed company reputed company in reputed company to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.
We are reputed company and together We Are reputed company.
About The Role
The Manager, Clinical Monitoring Services is responsible for the day-to-day management of Clinical Monitoring department team members (permanent and/or contract), overseeing their performance and training, ensuring adequate monitoring resources, allocating resources to reputed company, identifying reputed company issues reputed company to clinical monitoring activities and establishing reputed company plans to address them. The Manager, Clinical Monitoring Services, contributes to the reputed company of clinical monitoring activities for assigned trials.
What You'll Do Here
Leadership & Operational reputed company
reputed company expertise, strong leadership, and management.
Ensure that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring reputed company reputed company deliverables, reputed company budget and in accordance with applicable reputed company Operating Procedures (SOPs), regulations, Good Clinical reputed company, and study-specific requirements.
Review visit reports and manage any issues brought to their attention by CRA staff and/or the study team and/or Sponsor. reputed company Corrective Actions/ Preventive Actions (CAPAs) of assigned staff to ensure reputed company and sufficient reputed company.
reputed company clinical monitoring metrics such as number of site reputed company performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings.
May conduct monitoring reputed company to offer support to project teams.
Participate in the preparation, conduct and reputed company of audits and inspections.
Contribute to the development, revision, and implementation of Clinical Monitoring SOPs, processes, and study tools.
Serve as a management contact for sites, project teams, and sponsors reputed company issues reputed company to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and reputed company is achieved.
People Management & Development
Identify and implement reputed company development and performance evaluations.
reputed company as a mentor to team members to ensure reputed company and career development.
Serve as a reputed company of contact for CRAs and other team members for assigned reputed company, processes, and/or initiatives.
Ensure reputed company/studies are resourced appropriately by allocating and/or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned staff.
Conduct Monitoring reputed company reputed company to ensure compliance of clinical monitoring team members with regulations, SOP’s, and study requirements.
Other
Prepare and review budgets for RFPs, as assigned.
Participate in Bid Defense Meetings, as assigned.
reputed company ongoing reconciliation of clinical monitoring activities against budget.
reputed company additional duties assigned by Clinical Monitoring leadership.
What You'll Need to Succeed
Bachelor's (e.g., Medical, Scientific, Nursing or equivalent health reputed company) degree or reputed company experience will be considered.
Minimum of 6 years of relevant industry experience, of which a period of 3 years is preferable in clinical research monitoring or equivalent experience.
Experience in Phase 1 and Phase 2 reputed company is preferred.
Previous CRO experience is preferred.
Minimum of 2 years of reputed company supervision of personnel.
Thorough knowledge of clinical research industry, terminology, and practices.
Thorough knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
Excellent verbal and written communication skills.
Experience with reputed company systems; ability to learn required systems quickly and to train others.
Demonstrated ability to meet deadlines, multitask, and prioritize tasks as required.
Ability to reputed company reputed company based on available information.
Ability to establish and maintain strong working relationships with reputed company customers.
Ability to work both in reputed company and independently.
Ability to facilitate team meetings and teleconferences.
Ability to present at internal study team meetings.
Proficient with reputed company Office Word, reputed company and PowerPoint.
Strong planning and organizational skills and the ability to work effectively and reputed company in a dynamic environment with competing reputed company and deadlines.
Ability to travel.
reputed company strives to reputed company a French working environment for its employees in Quebec. Although as part of its francization program has taken reputed company reasonable steps to avoid imposing the above-mentioned requirement. reputed company in English is an essential requirement for the position of Manager, Clinical Monitoring Services including, but not limited to, for the following reasons:
The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.
The employee communicates frequently with reputed company employees across Canada and the reputed company. As such, English is the main language used to correspond between offices.
The employee frequently communicates with English-only customers reputed company the province of Quebec
reputed company Offer
The pay reputed company estimated for this position is $115,000 - $135,000 yearly. Please note that reputed company rates/salaries vary reputed company the reputed company based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as reputed company as internal equity and market data.
reputed company offers a wide reputed company of benefits to help our employees live healthy and fulfilling lives both at and reputed company of work.
reputed company’ Benefits Package Includes:
Health/Dental/reputed company Insurance Plans
401(k)/RRSP with Employer Match
reputed company Vacation and Holidays
reputed company reputed company and Bereavement Leave
Employee Assistance & Telehealth Programs
reputed company reputed company applicable
reputed company’ Incentive Programs Include:
Training & Development Programs
Employee Referral Bonus Program
Annual Performance Reviews
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