d) at IQVIA

Frankfurt, Hessen, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

Master’s or higher-level degree preferable in life science
Long term experience in clinical research, including at least 2 years of clinical trial management experience
Significant exposure in managing Early Phase clinical trials (Healthy Volunteer and Proof of Concept), including excellent understanding of the special business environment of Early Phase clinical trials
Exceptional knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Excellent understanding of project financials and effective vendor management
Effective communication skills, fluent language skills in German (at least C1 level) and good command of English
High ability to work on abstract complex topics

Responsibilities

Manage the execution of clinical studies or assigned portion of Early Phase clinical studies; including orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial
Work within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites
Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts, and necessary approvals
Ensure compliance with ICH-GCP and all other relevant regulatory regulations as well as accordance with client SOPs and values
Assure highest ethical and professional standards, patient safety, and that local component of trial is planned, conducted, and reported in line with regulatory requirements
Set up, manage, and review operating unit trial budget to ensure appropriate level of financial oversight and timely budget updates based on trial changes
Assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements
Ensure appropriate trial-specific training of internal and external partners in line with Trial Training Plan
Develop and maintain relationships with investigational sites and support CRAs in site contacts
In collaboration with Site Monitoring Lead and CRAs, ensure: provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, customer SOPs, and adherence to trial protocol; adequate trial supply distribution to sites; continuous and timely data entry and cleaning, and on time Data Base Lock; collection of required documents, with timely, complete, and compliant archiving of all relevant documents for the eTMF and CTR Appendices
Identify risks and contingencies and partner with project leader in problem solving and resolution efforts
Report to and relate with Trial Leader to provide updates, exchange critical information and share trial conduction information, within regulatory and compliance burdens
Participate in and actively drive organizational, quality and process improvement initiatives to commence future leading change

Skills

ICH-GCP

Clinical Trial Management

GCP Compliance

Regulatory Affairs

Vendor Management

Trial Budgeting

Early Phase Studies

Project Management

SOP Compliance

Patient Safety

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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