Dir Global Site & Study Operations

Budapest - Hungary

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Career Category

Clinical

Job Description

Accountabilities

The Country Study and Site Operations Head is accountable to drive all country and hub & spoke execution and quality measures including study operations site operations and site engagement while ensuring operational capabilities support the delivery of the geographic portfolio with high-quality data in compliance with local regulations.

Ensure study execution aligns with global strategies across trials and act as a key advisor for country commitments.

Provide leadership and line management to the Country/Hub team offering clear guidance fostering capability development and driving portfolio objectives.

Represent the country strategically in organizational initiatives at all levels.

Lead the Country Management Team (CMT).

Ensure adequate resourcing

Responsibilities

Accountable for all study execution in assigned geography and quality metrics including delivering study start-up patient enrollment retention trends and data flow metrics in alignment with global strategies across trials serving as key advisor for country commitments

Oversee clinical study budgets and forecasting to ensure efficient use of resources and financial accountability.

Build lead and develop the Country/Hub team to effectively manage resources ensuring appropriately skilled and high-performing staff to deliver the portfolio and meet organizational deliverables.

Drive country site engagement by leading SEL AD and/or SELs aligning with global strategy ensuring compliance strengthening partnerships and securing Partner-of-Choice positioning through innovation and leadership collaboration.

Shape and foster collaboration between local functional teams and global study teams to drive delivery of study portfolio in assigned geography

Partner with internal stakeholders to monitor study progress and drive local actions plan & issue resolution and aggregates country progress and challenges for senior management

Represent country in governance meetings communicating cross-study progress to region / CPSO

Advocate for study placement in considerations of strengths and growth opportunities of assigned geography

Lead internal and external meetings to ensure delivery on portfolio targets

Key advisor for site selection and identifies & communicates priority sites allocating resources as required

Point of escalation to support resolution of country-wide issues including risks which impact delivery or quality of clinical trials and/ patient safety

Lead country-level risk assessments and implement mitigation strategies to ensure patient safety compliance and trial continuity

Oversees vendor selection setup performance oversight across local roles (study delivery monitoring) in alignment with budget considerations and serves as point-of-escalation

Promote continuous improvement and best practice sharing to enhance operational efficiency and site engagement.

Build and develop strong local leadership and study teams to deliver on portfolio goals and support long-term organizational capability

Ensures adherence to key requirements (e.g. ICH-GCP SOP country regulations) study inspection readiness internal audits and CAPA processes

Work with SDRM to ensure timely and adequately resourcing for all roles

Authority

Country level oversight and delivery of clinical trials in alignment with Global Study Strategy

Authority over Country/Hub level trial operations site monitoring risk management resource allocation and stakeholder coordination

Lead the country site engagement strategy by guiding SEL AD and/or SELs to maintain compliance foster strong partnerships and achieve Partner-of-Choice status.

Outputs

Trial delivery and optimization of all global and local studies run within the country

Consistent quality in trial operations across studies in country

Effective leadership and development of a high-performing country team.

Strong strategic representation of country in global and regional initiatives and stakeholder engagements

Competencies

Understanding of global/local level regulations and compliance for clinical execution including concepts related to ethics submissions study start-up processes and site inspection readiness at global/regional level

Big picture pro-active thinking with the ability to assess broad impacts across multiple product portfolios to identify innovative solutions

Experience in assessing internal capabilities and identifying key capabilities to build training content monitoring skill improvement and drive competency builds across function and within teams

Experience in delivering portfolio/cross-study level budgets timelines and performance metrics (time cost quality) aligned to country/global / functional priorities.

Drive risk-based quality management adoption and understanding across organization

Leading expertise in country/global clinical trial processes operations with strong track record of program delivery across a country/regional/global portfolio

Experience driving and leading organizations through cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs

Adept in intra country and/or cross geography cultural dynamics and running efficient virtual country/global teams - Ability to lead and motivate geographically dispersed teams in an inclusive manner

Understand country regional trends/global impacting patient enrollment and patient safety compliance

Experience in assessing internal capabilities and identifying key capabilities to build training content monitoring skill improvement and drive competency builds across function and within teams

Proficient in driving and leading continuous improvement initiatives for teams working practices ensuring cross-functional adoption of new processes

Minimum Requirements

Doctorate degree and 4 years of clinical execution experience OR

Masters degree and 8 years of clinical execution experience OR

Bachelors degree and 10 years of clinical execution experience

In addition to meeting at least one of the above requirements you must have at least 4 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Requirements

10 years work experience in life sciences or medically related field including 8 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech pharmaceutical or CRO company)

Experience at or oversight of clinical research vendors (CROs central labs imaging vendors etc.)

Significant experience managing clinical operations across relevant geography / region including strong understanding of local regulatory requirements around global clinical trials

Career CategoryClinicalJob DescriptionAccountabilitiesThe Country Study and Site Operations Head is accountable to drive all country and hub & spoke execution and quality measures including study operations site operations and site engagement while ensuring operational capabilities support the deliv...