Senior Clinical Project Manager

Jobtailor; Deutschland; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor seeks a senior professional to independently lead the clinical trial study team and manage global pivotal trial activities. You will guide the clinical team, partner with R&D, Regulatory, Quality, and Marketing stakeholders, and develop PM plans while overseeing investigators and external vendors.

You will ensure IRB/EC activities, data management, and data lock processes are efficiently executed, maintaining strong PI relationships and robust study governance.

Qualifikationen

• Bachelor’s degree in a Life Sciences discipline required.
• Excellent English with advanced medical/scientific writing skills.
• Proven experience authoring clinical study protocols.
• Experience managing global clinical trial activities and vendors.

Aufgaben

• Lead the clinical trial study team and manage global activities.
• Develop project management plans and oversee IRB/EC processes.
• Coordinate with R&D, Regulatory, Quality, Marketing to align goals.
• Identify, train investigators and manage external vendors.

Kenntnisse

English writing

Protocol authoring

Presentation skills

Medical device trials

Biostatistics

Project management

Regulatory liaison

Vendor management

Leadership

Stakeholder management

Ausbildung

Bachelor’s degree in Life Sciences

Tools

Clinical trial management systems

Biostatistics software

Data management tools

Jobbeschreibung

Responsible for independently leading the clinical trial study team. Managing global clinical trial activities on pivotal trial. Effectively communicates and guides clinical team members. Partners effectively with R&D, Regulatory, Quality, Marketing/Product stake-holders. Management of all clinical studies including developing project management plans. Identification, qualification, and training of investigators and teams. Responsible for the activities related to IRBs/ECs, and clinical study vendors. Proactively manage the data management and data lock processes. Great site relationships with the PI and coordinator

Requirements

• Bachelor’s degree in a Life Sciences discipline required
• Exceptional proficiency in professional English, with advanced medical and scientific writing skills
• Demonstrated experience authoring clinical study protocols
• Strong presentation and communication skills
• Comprehensive knowledge of the medical device clinical trial lifecycle
• In-depth understanding of medical device clinical research
• Solid understanding of biostatistics and clinical data interpretation
• Minimum of 5–6 years of progressive experience in clinical project management
• Experience working directly with regulatory authorities
• Proven ability to manage and oversee external clinical vendors
• Excellent organizational, leadership, and stakeholder-management skills

Core Competencies

Demonstrates expertise in managing global clinical trial activities, including project management, regulatory compliance, and stakeholder engagement. Proficient in clinical study protocol development, data management, and biostatistics interpretation.

Highest-signal resume keywords

• Clinical Project Management
• Clinical Study Protocol Authoring
• Medical Device Clinical Research
• Regulatory Authority Interaction
• Stakeholder Management

ATS Optimization Keywords

Hard Skills

• Clinical Trial Management
• Biostatistics
• Data Management
• Clinical Data Interpretation
• Medical Writing

Soft Skills

• Leadership
• Communication
• Presentation
• Organizational Skills

Industry Keywords

• Life Sciences
• Clinical Trial Lifecycle
• Investigational Review Boards
• External Clinical Vendors
• Pivotal Trials