Associate Director, Clinical Operations at United Biosource Corporation
Deutschland, , Germany -
Full Time


Start Date

Immediate

Expiry Date

28 Aug, 25

Salary

0.0

Posted On

28 May, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Clinical Research Experience, Drive Change, Line Management Experience, Drug Development, Global Teams, Regulatory Guidelines, Color, Clinical Monitoring, Clinical Trials, Statistics, Analytical Skills, High Pressure Situations

Industry

Pharmaceuticals

Description

Brief Description:
Provide operational and strategic leadership to effectively manage the activities of a regional clinical operations team. Ensure delivery targets are met with highest quality, while balancing productivity, revenue and margins. Fulfill general responsibilities with regard to hiring, training, resourcing, coaching, performance management, and functional delivery of respective staff. Direct reports may include CTS, CSS, CRA, Manager and Sr. Managers of Clinical Research.

DESIRED SKILLS AND QUALIFICATIONS:

  • Advanced Degree preferred, bachelor’s degree or equivalent experience required.
  • Significant clinical research experience (comparable to 10 years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out
  • Line management experience (5 years) appropriate to the size and complexity of the clinical management group in the designated country/region
  • Demonstrated ability to work with diverse, global teams
  • Excellent mentoring/leadership/supervisory skills
  • Advanced knowledge of clinical trials monitoring: remote and on-site
  • Strong knowledge of FDA/ICH regulatory guidelines
  • Working knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics, and regulatory/medical writing)
  • Exceptional problem-solving and analytical skills with willingness and ability to detect process gaps, challenge assumptions, and drive change and improvement
  • Ability to work in a team environment under high pressure situations
  • Strong influencing and negotiation skills
  • 20% travel as requiredUBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

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Responsibilities
  • In partnership with project teams, provide oversight of overall functional quality, operational and financial delivery. Drive the department to achieve utilization and productivity targets at the regional level.
  • Understand revenue drivers and costs for the department and contribute to budgetary discussions, as appropriate, to ensure profitability.
  • Ensure all EDO Resources within assigned team are meeting or exceeding performance objectives for productivity and quality and take appropriate remedial actions and/or escalations as required.
  • Ensures allocated resources are aligned with current and forecasted work in terms of capability, quantity, timing, and efficiency.
  • Ensure agreed corrective and preventative actions are implemented, and/or further training is received, as required.
  • Lead the development of clinical, functional and people manager trainings; drive change within operations in collaboration with other departments and functions, to embrace and enforce the current and changing paradigm of clinical research.
  • Lead initiatives that enhance departmental performance and/or lead to process improvement across UBC.
  • Manage team of clinical operations professionals and promote an effective and collaborative environment in which best practices are shared.
  • Provide the experience and ability to manage client portfolios at the functional level, as applicable, by serving as the clinical subject matter experts.
  • Ensure that monitoring is conducted within budget to maintain departmental margin parameters.
  • Act as key contact for the country/region for operational questions and escalations, both internally and externally.
  • Ensure Inspection Readiness is maintained at all times.
  • Act as functional area lead in country wide business development activities, as appropriate.
  • Act as role model for the team and reinforce UBC core values.
  • Other duties as assigned by management.
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