Job description

Duration: 12 months (possible extension)

Description:
Purpose, Objectives and Scope of Position

The Country Study Manager (CSM) provides leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with Client quality standards, all applicable regulations, timelines and budget commitments.
For Global/Regional Studies (referred as Global), the CSM leads and has full accountability (time, quality, cost) in alignment with the Study Management Team (SMT) For Local Studies, the CSM acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for the local study team.

Key Responsibilities

Has full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Client planning system.
Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required. Leads local study teams, represents Country/Region Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global).
Plans and executes country study goals and commitments and ensures compliance to relevant processes.
May serve as global Country Study Representative (CSR), as part of global study team. Coaches and provides support to responsible study team members.
Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Client studies.
Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required

Qualifications
Education

Degree (MD, PhD, MA / MS, BA / BS) in life sciences or equivalent. Postgraduate degree or master’s degree will be valued but not required (depending on each country’s requirements).

Experience

Experience in the pharmaceutical or related industry.
Experience in end-to-end product development.
Understanding of end-to-end clinical trial processes, and strong knowledge of clinical trial regulations and guidelines.
Proven track record in managing site relationships and overseeing complex clinical trials.
Fluency in written and spoken English is mandatory.
Fluency in written and spoken language(s) of the host country is mandatory.
Ability to travel to meet the demands of the job: travel to sites on an on-going basis to establish and maintain strong working relationships. Frequent International and/or domestic travel may be required.

Skills

Demonstrated customer centric mindset and behaviors, building trust and positive and strong sustainable relationships with external and internal stakeholders and CROs.
Exceptional communication and interpersonal skills, with the ability to build and maintain positive relationships with site personnel, and other external and internal stakeholders.
Proven influencing and negotiation skills.
Problem-solving: Proactively identify challenges and develop effective solutions by using analytical thinking, tools, and judgement.
Ability to manage multiple priorities and work in a fast-paced, dynamic environment.
Team Collaboration: Ability to work within cross-functional teams and foster collaborative relationships.
Strategic Leadership with the ability to demonstrate flexibility and agility working cross-functionally and leading through ambiguity.
Critical thinking and growth mindset.
High ethical standards and professionalism.
Proactive, results-driven attitude

Impact Levels

Solid clinical research knowledge and expertise in clinical trial operations, DA portfolio knowledge, cultural awareness and local language(s) management to deliver a site-facing customer experience focused on efficiency and speed. Good understanding of end-to-end clinical trial process.
Good communication and interpersonal skills, with the ability to build and maintain positive relationships with site personnel, and other external and internal stakeholders. Demonstrate good influencing and negotiation skills.
Demonstrated solid customer centric mindset and behaviors, building trust, positive and strong sustainable relationships with external stakeholders to ensure high levels of site satisfaction. Experience in managing and maintaining solid site relationships.
Proactively identifies challenges and develops effective solutions by using analytical thinking, tools, and judgement.
Demonstrated ability to work within cross-functional teams and foster collaborative relationships. At sites participating in clinical trials, builds strong relationships to engage on study level topics.

Qualification Levels

Degree (MD, PhD, MA / MS, BA / BS) in life sciences or equivalent. Postgraduate degree or master’s degree will be valued but not required (depending on each country’s requirements)
Experience in the pharmaceutical or related industry.
Experience in product development.
Good understanding of end-to-end clinical trial processes, and solid knowledge of clinical trial regulations and guidelines.
Experience in managing site relationships and overseeing clinical trials.

Note:

Work Location: This is a remote role. Candidate is not mandated to work from the office but must reside in Canada

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

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Country Study Manager (CSM) # 26-15503

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