We work to fight poverty and achieve social justice by empowering women and girls. www.CARE.org
Clinical Trial Manager
Location
Canada
Posted
9 days ago
Salary
0
Seniority
Senior
Job Description
Clinical Trial Manager
CARE
• Drives and Manages studies or projects according to scope of work, timelines, and quality standards. • Supports building a strategy to deliver the trial or project as per protocol and timelines. • Monitors and analyses project status to ensure successful completion of project parameters, milestones, timetables. • Understands proactively manages risks on trials or projects and implements mitigations whilst working in a cross functional team. • Acts as principal liaison between Sponsor and Care Access by facilitating the flow of information between Care Access and client. • Appropriately escalates any issues or potential issues as per escalation pathways; and provides timely project updates to upline management and/or Senior Leadership at Care Access. • Coordinates a cross functional team to support delivery of the clinical trial. • Holds teams accountable for delivery and success of the trial. • Leads teams to successfully deliver in their areas. • Coordinates activities of all functional departments and vendors involved in the project. • Works with team and management to develop plans/guidelines for project implementation using Care Access tools. • Identifies data and analytics required to allows data-driven decisions and continuously monitors ongoing project performance. • Evaluates growth opportunities of current engagement or potential engagements; helps develops the strategy for various initiatives. • Works with team to identify potential risks, develop contingency plans. • Plans and communicates to team members to study specific tasks and priorities for projects. • Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed. • Maintains project logs and trackers. • Supports essential documentation and follow up of monitoring visits • Provides recommendations and alternative resolutions to project-specific challenges through established escalation channels. • Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. • Escalates identified findings from periodic quality reviews and peer feedback reports. • Collaborates with fellow CTMs and department leadership on best practices. • Lead the process of study startup to support site evaluation/selection visits on each new study and help to have sites selected and successfully activated, based off of study requirements. • Review study information and liaise with key stakeholders across the global organization to communicate study/site needs, requirements, performance expectations and establish timelines. • Work closely with the staff onsite to help address questions, assess risks and mitigate issues throughout startup. • Partner with other Care Access teams to initiate study related processes at the appropriate SSU milestone (e.g. capacity planning, systems build requests, etc.). • Partner and communicate with client to drive startup activities, timelines, and expectations of Care Access startup process. • Ensure that all information gained during the startup process is completely transitioned to sites, as required. • Continue to assess and optimize study start up processes to enhance efficiency and productivity. • Monitor key performance indicators to track progress and identify areas of improvement. • Be main point of contact with the sponsor to drive study activation.
Job Requirements
- Must have clinical trial experience.
- Decentralized clinical trial experience, preferred.
- Site experience, preferably in a site network.
- PMP Certification, preferred.
- Bachelor's degree
- Must have 6+ years of experience in the clinical trial/pharmaceutical industry.
- Must have 4+ years in project management including client management.
- Must have 1-2 years strategy consulting experience.
- Experience with oversight of external vendors (e.g., e-consent vendor).
- Experience collaborating and leading cross-functional teams in a matrix environment.
- Experience managing multiple projects across various therapeutic areas.
- Experience anticipating and resolving problems on projects.
- Experience reporting project details to various stakeholders within the company and outside of the company
Benefits
- Paid Time Off (PTO) and Company Paid Holidays
- Medical, dental, and vision insurance plan options
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