Job Closed
This listing is no longer active.
Country Study Operations Manager
Location
Canada
Posted
36 days ago
Salary
0
Seniority
Senior
Job Description
Country Study Operations Manager
Parexel
• Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables • Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies • Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans) • May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable • Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs) • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Accountable for resolution of site activation escalations to study teams including offering options for mitigation • May be responsible and accountable for, as designated by the GSM: o Regional, country and study level implementation of startup and site activation plans (through SUPM or pCRO if assigned) o Regional, country and study level recruitment strategy o Support of the development of study level plans o Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plans o Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables o Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc.
Job Requirements
- Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
- Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
- Comprehensive knowledge of own discipline with good knowledge of other disciplines to ensure that the study can meet its goals and to serve as a resource for others
- Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
- Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
- Demonstrated clinical research experience and/or study management/startup project manager experience
- Demonstrated experience in managing country level operational activities and/or vendors
- Experience in study and quality management
- Knowledge of clinical trial methodology
- Ability to work outside of core business hours, as required, to support global trials or initiatives
- Ability to travel, as required, including Investigator Meetings, vendor kick off and re-set meetings, and client internal global or department level meetings
- Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization
- Fluency in written and spoken English required.
Benefits
- Health insurance
- Flexible working hours
- Professional development opportunities
Related Guides
Related Categories
Related Job Pages
More Operations Jobs
Pre-Sales Architect – Dynamics 365 FSCM, FinOps
Hitachi Solutions AmericaA global cloud-services, systems integrator with leading capabilities across all Microsoft applications and technologies
• You qualify opportunities together with the Commercial Lead and define the engagement approach. • You design and present solutions (materials, demos, presentations — also at events). • You run customer workshops and translate requirements/agenda into a robust solution vision. • You coordinate internal stakeholders (Sales/Delivery/Marketing) and drive the pre-sales process end-to-end. • You identify and document compelling customer success stories/references that demonstrate our capabilities and successful projects. • You support proposal work and customer meetings with a clear storyline, effort estimates, and commercial input.
Senior Service Operations Analyst
ExperianBased in Dublin, Leinster, Ireland, Experian is a global information services company that operates in 40 countries around the world and has additional headquar
• Coordinate Problem Management activities, including tracking problem records, actions, and closure steps. • Schedule and support RCA sessions, ensuring outcomes and follow‑ups are clearly documented. • Monitor corrective actions to ensure ownership, progress, and completion. • Create and maintain dashboards and reports to share operational insights and trends. • Support Change Management by reviewing change records and coordinating change and release activities. • Identify opportunities to improve processes through automation, better tools, and AI‑assisted solutions.
Executive Director, Edit Strategy and Operations
People Inc. PublishingPeople Inc. is a major American digital and print media company founded in 1997 as The Mining Company, later renamed About Inc., Dotdash, Dotdash Meredith, and now rebranded as Peo
Lead strategic planning and execution to drive audience growth and engagement, oversee content operations and production, and optimize user experience through collaboration with cross-functional teams to achieve business goals.
Registrar (Summer Only, Part-time) locations Texas (Remote) Tennessee (Remote) South Carolina (Remote) Georgia (Remote) time type Part time job requisition id R261 Pine Cove is a growing non-profit organization that offers a wide variety of professional, impactful, and fun full-time jobs. We are frequently looking for additional ministry-minded individuals to join our team in various departments such as marketing, accounting, registration, information technology, human resources, and more! Job Description Summary: This position is a seasonal, summer-only (May to August) and is responsible for all duties of registration, communication, and housing process of individuals and groups for all summer camp or Pine Cove-sponsored conferences. Specific areas include: fostering long-term relationships through outstanding customer service and Follow-up sales support and after-contact marketing which is critical in this role. This position exemplifies the core values of Pine Cove by being Christ-centered, others-focused, and seriously fun. Job Description: Job Responsibilities - Manage the registration, communication, and housing for Camps and Conferences. - Provide excellent customer service to all current and potential guests. - Maintain and manage an accurate database. - Assist with follow-up calls to current and potential campers as an active part of the registration loop. - Responsible for other tasks as directed. Job Qualifications - Agrees with and exhibits behaviors in accordance with the Pine Cove Statement of Faith - Maintain compliance with all Pine Cove policies and procedures during employment including the Staff Policy Handbook - Maintain compliance with all state and federal laws - Must establish and maintain professional working relationships with employees, managers, and external constituents, including demonstrating consistent Speed of Trust behaviors - Is self-motivated with a desire to serve and do all things with excellence - Adjusts to changes in environment or schedule while maintaining a joyful attitude - Possess current driver’s license and able to drive company vehicles as needed - High School Diploma preferred - 1+ year of camping or customer service experience preferred - Strong digital, verbal, and written communication skills - Strong organization and attention to detail skills - Basic knowledge of computer systems, aptitude to learn new software - Autonomy to work independently with a team player attitude Pine Cove exists to be used by God to transform the lives of people for His purposes and His glory! We are not only a high-energy and creative environment but also a life-transforming and rewarding workplace. Apply to be a part of this “Christ-centered, others-focused, seriously fun” ministry today!


