d) at IQVIA

Frankfurt, Hessen, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Master’s or higher-level degree in life sciences or related field. An education as a physician would be a plus
Minimum of 5 years (or 10 years for Senior CTL role) of global clinical operations management experience, preferable within a global CRO environment
Experience in set-up and conduct of Phase II clinical trials including in depth knowledge of early phase study designs, protocol writing and clinical pharmacology. Additional experience in conduct of Phase I and Phase III trials would be an advantage
Knowledge of applicable clinical research regulatory requirements e.g. GCP / ICH guidelines and relevant local laws
Therapeutic area knowledge in any of the following would be an advantage: respiratory, inflammatory, cardiovascular - metabolic, CNS, oncology
Computer skills including good knowledge of Microsoft Word, Excel and PowerPoint
Fluent language skills in English and good knowledge of German at preferably least C1 level
Effective communication, organizational and problem-solving skills
Strong leadership competencies and ability to establish and maintain effective working relationships

Responsibilities

Leading global cross-functional project team delivery, being accountable for trial oversight, achievement of trial milestones and trial quality
Serving as the primary contact within the customer for trial progress and governance
Developing study management plans and further documents for complex phase I and phase II trials (including authoring trial protocol and protocol synopsis, ICF, integrated Quality plan, etc.)
Takes medical and/or scientific decisions (for non-medics in alignment with MD colleagues at the customer) and provides strategic input for early clinical development
Ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures
Leading (interdisciplinary) of the core trial teams (e.g.: trial data managers, trial statistician, trial pharmacokinetics and clinical trial manager,…)
Leading the Trial Oversight Meeting (as applicable)
Collaborating with other functional groups within the client where necessary to support milestone achievement and to manage study issues and obstacles
Consulting with pharmacogenetics experts on preclinical and medical aspects as well as side effects (including SAEs and SUSARs)
Anticipating project risk and implementing mitigation strategies

Skills

Clinical Trial Management

Study Management Plans

Trial Protocol Authoring

Cross-Functional Team Leadership

Trial Oversight

Phase I Trials

Phase II Trials

Quality Management

Data Management

Statistics

Pharmacokinetics

GCP Compliance

Risk Management

Stakeholder Management

Early Phase Development

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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