Country Study Operations Manager / Clinical Trial Manager - Canada - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Summary:
The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.

Key Accountabilities:
Study Management Oversight
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 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)

Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning

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:

Regional, country and study level recruitment strategy

Support of the development of study level plans

Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plans

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.

Study Management Operations
Acts as the point of contact for all study level questions for the local study team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles and teams

May lead operational effectiveness initiatives at country or regional level

Utilizes roles in country such as Lead SCP, and expert roles such as Contracts Leads and SAPs, to provide the global teams with local intelligence and operational nuances to be considered

Provides input on country level per subject costs, local vendor costs, and other fees where applicable Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan and Study Monitoring Plan, and ensures Trial Master File (TMF) completeness and oversight of all relevant compliance activities for allocated studies Supports implementation of client’s site technology experience systems

Supports implementation of new tools and technologies (e.g., eConsent, eISF, remote source access, remote source data verification/review (SDV/SDR), iConnect, implementation of protocol required decentralized trial options)

Compliance with Parexel Standards
Complies with required training curriculum

Completes timesheets accurately as required

Submits expense reports as required

Updates CV as required

Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills
Expertise in the use of study and site dashboards and reporting tools

Detail oriented and possesses technical expertise

Ability to manage moderately complex processes

Risk identification and mitigation, strategic planning, and critical path analysis skills

Analytical and problem solving skills

Ability to adapt to changing technologies and processes, work independently and exercise own judgement

Supportive of an environment where innovation is standard, including developing ideas and taking appropriate risks to advance innovative processes

Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization

Ability to operate in a matrix environment

Fluency in written and spoken English required

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

Knowledge and Experience:
3-5 years clinical trial study management 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

Experience working in a matrix management environment

Relevant operational clinical trial experience

Education:
Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial operations experience required OR Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required

A scientific or technical degree is preferred

#LI-CF1