Country Trials Manager - FSP

About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Job Title: Country Trials Manager (CTM)

Position Purpose:

The Country Trials Manager (CTM) is responsible for study startup deliverables for assigned studies at a country level of limited or moderate complexity. The Country Trials Manager partners with the Study Start Up Project Manager (SUPM), Study Manager (SM), Site Intelligence Lead, Site Relationship Partner (SRP), Site Activation Partner (SAP), Contracts Lead, Regulatory Affairs, CRO representatives and others as required. The Country Trials Manager provides leadership and country strategic planning and organization skills to ensure the delivery of operational Start up aspects of one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.

Accountable for the execution of:

• Country level implementation of Startup and Site Activation Plans

• Country level Recruitment Strategy

• Timely and quality Ethics Committee (EC)/Regulatory Authority (RA) Submissions • Communication with internal stakeholders as listed above to ensure efficient and timely study startup delivery at a country level

Primary Duties:

Responsible for Study and Site Start Up on a Country level:

• Manages the study start up process in countries assigned

• Supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements • Provides country level input on Startup and Recruitment milestones to Global Study Team during planning

• Is accountable for delivery of startup and site activation for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g., timelines, budget, risk and quality plans)

• Highlights deviations and risks in startup and site activation plans to relevant parties, develops and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation (both at the study and site level)

• Attendance at SSU meetings. Ad-hoc member of the Operational Study Team Meetings

• Leader of the Local Study Team (core members: Country Trials Manager, Site Relationship Partner, Site Activation Partner, ad hoc members: Contracting, Regulatory, Medical Affairs colleagues and other key stakeholders)

• Ensures timely communication bidirectionally between the global and local study team

• Provides protocol level guidance and support to responsible Local Study Team members as applicable

• Liaise with Global Site and Study Operations and Regulatory colleagues and country colleagues to agree on submission strategy to Health Authorities and Ethic Committees

• Provides Global Teams with local intelligence. Acts as the main point of contact for all study-level questions for the Local Study Team, liaising with and escalating to appropriate global roles/teams Follows up on country level issue status to ensure resolution. Identifies start up country level trends to improve start up processes as needed

• Ensures compliance to relevant Global and Local, internal and external processes

• Ability to successfully liaise with global roles in support of successful CT (clinical trial) implementation at a country level

QualificationsSkills and Education:

• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/ experience: BS/BSc/MS/MSc; a nursing diploma or associate degree in nursing may also be considered with extensive clinical trial experience

• Operational clinical trial experience

• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility

• Fluency in English and region/country local language are required

• Prior Experience Preferred:

• + 5 years of clinical research experience and/or study management/startup project manager experience

o Demonstrated knowledge of site selection, site activation, site readiness interdependencies

o Demonstrated knowledge of clinical trial methodology and the drug development process

o Demonstrated experience leading cross functional teams

o Demonstrated experience in Project Management and Quality management

o Demonstrated experience in a matrix management environment

• Expertise in the use of Site Activation tools

• Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)

• Ability to manage complex processes

• Ability to manage in a matrix environment

• Risk Identification and Mitigation

• Strategic Planning, Analytical and Problem-Solving Skills

• Critical Path Analysis

• Excellent communication skills, both written and verbal

• Ability to adapt to changing technologies and processes

• Seeks to develop an integrated view of key issues to shape decisions and strategy development

• Proactively manages change by identifying opportunities and coaching self and others through the change

• Ability to introduce new ideas and implement them

• Effectively overcoming barriers encountered during the implementation of new processes and systems

• Builds effective relationships with customers and other stakeholders

• Works well across country boundaries, respects communication and cultural differences in interpersonal relationships

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