17.10.2026 aktualisiert

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Clinical Operations Lead: national and international Clinical Trials, NIS, IIT, PMCF

Ebersberg, Deutschland
Weltweit
Diploma in Economic Chemistry, University of Ulm
Ebersberg, Deutschland
Weltweit
Diploma in Economic Chemistry, University of Ulm

Profilanlagen

CV_Rupert_Lang_EN_ClinOps_202610.pdf

Über mich

Clinical Operations Lead with 18+ years in clinical research. I lead national and international trials (AMG/CTR, MDR, ICH-GCP), NIS, IIT and PMCF from set-up to close-out, incl. oversight, timelines, budgets and escalations. Calm, analytical, pragmatic.

Skills

Change ManagementKlinische ArbeitenVerwaltung Klinischer DatenKlinische FührungClinical Research CoordinatorClinical TrialsClinical Trial Management SystemInterim ManagementProjektmanagementMedizinproduktenArzneimittelrecht
Clinical Operations Leadership
18 years of hands-on clinical operations and project management under AMG/CTR/ICH-GCP, ISO 14155 and MDR, from set-up to close-out, across pharma, MedTech, CROs and academic sponsors.

Non-Interventional Studies, IIT & Real-World Evidence
Planning and conducting NIS, IIT and registry/PASS studies; trainer on non-interventional studies.

Process & Organizational Development
Process standardization and optimization incl. RBQM, (e)CTMS, EDC (Clincase, SecuTrial, Climedo), eTMF oversight and safety frameworks.

Budget & Cost Management
Cost estimation and budget governance for clinical projects (budgets above EUR 20M) across therapeutic areas; P&L responsibility for portfolios of EUR 10–15M.

Medical Devices & PMCF
PMCF and clinical evaluation under MDR (previously MPG) and ISO 14155 for device manufacturers; drug and device regulatory frameworks.

Client & Vendor Management
Client and stakeholder management, vendor oversight and negotiation (e.g. partner CROs) across national and international projects; escalation point beyond project level.

Team & Project Stabilization
Repeatedly entrusted with vacant leadership roles and transitional situations; stabilizes teams, operations and critical client situations.

Team Leadership
High-performing teams; turnover consistently below 5% p.a. versus 20%+ industry average.

AI & Digitalization
Founded and led an AI working group; evaluated AI applications in clinical research and derived use cases.

Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2026

Sprachen

DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisse

Projekthistorie

Clinical Operations Lead – Clinical Trials, NIS, IIT, PMCF

Self-employed
Clinical Operations Lead for clinical trials, NIS, IIT and PMCF for pharma, MedTech, CROs and academic sponsors in the DACH region. Focus on study oversight, process modernization, escalation management and stabilization in transition situations.

Managing Director - Chief Executive Officer

GKM Gesellschaft fur Therapieforschung mbH, Munich

Pharma und Medizintechnik

50-250 Mitarbeiter

Responsible for the operations of a CRO with 100 employees (17 direct reports, more than 80 indirect), incl. P&L of EUR 10–15M. Final escalation point for client escalations. Led the RBQM process transformation, a company-wide business process management framework and the AI working group; change and process management, operational leadership.

Managing Director - Chief Operating Officer

GKM Gesellschaft fur Therapieforschung mbH, Munich

Pharma und Medizintechnik

50-250 Mitarbeiter

Responsible for operations; sparring partner for all project budgets exceeding EUR 20M.

Corporate Operations Manager (Change & Process Management)

GKM Gesellschaft fur Therapieforschung mbH, Munich
Budget and team management with EUR 20M project budgets and people management for 65 staff. Areas covered: operational and escalation trouble-shooting, budget sparring/controlling, project oversight of all clinical projects. Designed and rolled out a ticket-based case-assignment system for the Safety group.

Group Lead, Sponsor Team (alongside the Senior Project Manager role)

GKM Gesellschaft fur Therapieforschung mbH, Munich

Pharma und Medizintechnik

50-250 Mitarbeiter

Team lead for a group of 5-25 employees. Developed a CRA performance-rating system together with the department and QA, built as a Microsoft Access database with bi-annual reviews and CAPA plans.

Senior Project Manager

GKM Gesellschaft fur Therapieforschung mbH, Munich

Pharma und Medizintechnik

50-250 Mitarbeiter

Budget up to EUR 3M per project, managing national and international clinical studies (medicinal products and medical devices), NIS, IIT, PMCF, non-AMG/non-MPG projects. Promoted to Senior Project Manager in under 3 years.

Project Manager

GKM Gesellschaft fur Therapieforschung mbH, Munich

Pharma und Medizintechnik

50-250 Mitarbeiter

Budget approximately EUR 2.5M study carried over from the Junior Project Manager stage, plus further budgets up to EUR 2M per project. Brought in by senior management to stabilize a key account with a strained client relationship.

Junior Project Manager

GKM Gesellschaft fur Therapieforschung mbH, Munich

Pharma und Medizintechnik

50-250 Mitarbeiter

Budget approximately EUR 2.5M as the responsible project manager of an international 11-country study. Took over the study in the absence of the responsible PM and delivered it successfully.

Project Manager / Project Assistant

MedPharmTec Services GmbH, Munich

Pharma und Medizintechnik

10-50 Mitarbeiter

Project Manager for post-marketing studies (02/2009-04/2013) with parallel proof-reading and labelling-compliance responsibility; before that Project Assistant for post-marketing studies (08/2008-01/2009). Support and management of non-interventional studies, including data management, safety and IT-related tasks.

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