Site Operations Manager – Contractor

Jobtailor; Deutschland; Remote; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks a Clinical Study Manager to lead end-to-end study delivery, manage budgets and timelines, and coordinate cross-functional teams in a matrix environment.

The role requires 2+ years in clinical study management, strong communication skills, and the ability to adapt to a fast-changing environment. Travel up to 20% may be required. You will interact with sponsor project teams and client study teams to ensure quality and compliance.

Qualifikationen

• Bachelor’s degree or equivalent applicable experience required.
• Minimum of 2+ years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience required.
• Advanced degree or equivalent clinical research experience preferred.
• Medical and scientific knowledge preferred.
• Knowledge in study management and ability to successfully manage multiple clinical studies.
• Ability to adapt to a rapidly changing work environment and manage competing priorities.
• Ability to travel up to 20% as needed.

Aufgaben

• Deliver clinical studies on time and on budget while meeting quality standards.
• Lead multifunctional Study Management Teams in a matrix environment.
• Plan, solution, recruit, execute, and close out clinical studies within client agreements.
• Oversee operational aspects of clinical trials in compliance with SOPs, GCP/ICH guidelines, FDA and state regulations.
• Serve as the primary point of contact for client study teams and sponsor project teams.
• Develop project management plans covering planning, execution, closeout milestones, communication, and contingencies.
• Develop and monitor study metrics to assess study progress.
• Lead internal and external project team meetings.
• Track study status, timelines, budgets, risks, data entry, queries, and data issues.
• Coordinate study resources and staffing within budget.
• Identify out-of-scope work and support budget or contract change orders.
• Review study budgets, expense reports, financial records, invoicing, units, and expenses.
• Maintain timely records in time-tracking, project-management, and resource-planning software.
• Support study audit preparations.
• Develop, oversee, and deliver project-specific team training.
• Collaborate on study documents and manuals, including ICFs, manuals, presentation decks, and risk plans.
• Establish project processes, communicate performance expectations, and manage external service providers.
• Provide performance evaluation input for project team members and service providers.
• Understand customer needs and influence decision-making.

Kenntnisse

Project management

Team leadership

Communication

Problem solving

Adaptability

English communication

Ausbildung

Bachelor’s degree

Advanced degree preferred

Tools

MS Office Suite

Google Applications

Project Management Software

Time-Tracking Software

Resource-Planning Software

Jobbeschreibung

• Deliver clinical studies on time and on budget while meeting quality standards
• Lead multifunctional Study Management Teams in a matrix environment
• Plan, solution, recruit, execute, and close out clinical studies within client agreements
• Oversee operational aspects of clinical trials in compliance with SOPs, GCP/ICH guidelines, FDA and state regulations
• Serve as the primary point of contact for client study teams and sponsor project teams
• Develop project management plans covering planning, execution, closeout milestones, communication, and contingencies
• Develop and monitor study metrics to assess study progress
• Lead internal and external project team meetings
• Track study status, timelines, budgets, risks, data entry, queries, and data issues
• Coordinate study resources and staffing within budget
• Identify out-of-scope work and support budget or contract change orders
• Review study budgets, expense reports, financial records, invoicing, units, and expenses
• Maintain timely records in time-tracking, project-management, and resource-planning software
• Support study audit preparations
• Develop, oversee, and deliver project-specific team training
• Collaborate on study documents and manuals, including ICFs, manuals, presentation decks, and risk plans
• Establish project processes, communicate performance expectations, and manage external service providers
• Provide performance evaluation input for project team members and service providers
• Understand customer needs and influence decision-making

Requirements

• Bachelor’s degree or equivalent applicable experience required
• Minimum of 2+ years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience required
• Advanced degree or equivalent clinical research experience preferred
• Medical and scientific knowledge preferred
• Knowledge in study management and ability to successfully manage multiple clinical studies
• Proactive problem-solving abilities and follow-through
• Ability to adapt to a rapidly changing work environment and manage competing priorities
• Successful decentralized team management and situational responsive decision-making
• Extensive knowledge of clinical research, drug development process, clinical research industry, and relevant operating environments
• Ability to review protocols and assess program and project risks
• Experience building and guiding organizational teams
• Strong written, verbal communication, and presentation skills
• Working knowledge of MS Office suite and Google applications
• Willingness to gain expertise in proprietary software
• Ability to manage and track multiple study budgets with understanding of study financials
• Ability to communicate in English, both verbal and written
• Ability to travel up to 20% as needed

Core Competencies

Demonstrates expertise in clinical study management, including planning, execution, and compliance with regulatory standards. Proficient in managing budgets, resources, and team dynamics while ensuring quality and timely delivery of clinical trials.

Highest-signal resume keywords

• Clinical Study Management
• Regulatory Compliance
• Budget Management
• Project Management
• Team Leadership

ATS Optimization Keywords

Hard Skills

• Clinical Research
• Study Management
• Drug Development Process
• Protocol Review
• Risk Assessment
• Study Metrics Development
• Financial Tracking
• SOP Compliance
• GCP/ICH Guidelines
• Data Management

Soft Skills

• Proactive Problem-Solving
• Adaptability
• Communication Skills
• Team Management
• Decision-Making

Industry Keywords

• Pharmaceutical
• Biotech
• Clinical Trials
• Study Budgets
• Client Agreements
• Study Closeout
• Decentralized Team Management
• Study Audit Preparation
• Client Study Teams
• Sponsor Project Teams

Tools & Technologies

• MS Office Suite
• Google Applications
• Project Management Software
• Time-Tracking Software
• Resource-Planning Software