Senior Clinical Project Manager (d/f/m)

Jul 07, 2021

Job Description

200! That is the number of studies we conduct in Germany every year!

Novartis is a global pharmaceutical company. Our goal is to redefine medicine in order to improve and prolong people's lives through the application of innovative science and technology.

We are committed to development - developing innovative compounds that serve the needs of a growing, aging population and developing new and innovative ways to reach people in low-income countries.

We invest in the most promising areas of science, in the most exciting innovations in the medical field, and in the most important needs of health care.

We are convinced that the best solutions are found in a team!

We are Novartis. Join us and help us reimagine medicine.
Within this very innovative environment we are currently hiring the

Senior Clinical Project Manager (m/f/d)

job purpose

The Senior Clinical Project Manager (f/m/d) is leading and managing a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and MAP/PTA/IIT programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures.

Your responsibilities

• Accountable for investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence

• Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with Novartis global standard and local regulatory requirement

• Support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated NBS CONEXTS, Novartis line functions and CRO Partners as required. Also if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions

• In collaboration with the NBS CONEXTS or Customer data review team (Central data Monitors, Data Managers, Statisticians, and third parties), contribute to the study data ongoing medical/scientific data quality review to ensure high quality data are trans-ferred/available in a timely manner

• In partnership with Clinical Operations Specialists (COS) (where applicable) accountable for the set up and maintenance of the Trial Master File (TMF) and Clinical Trial Management System (CTMS) for studies/programs

• Accountable for the development, management and tracking of study budget (internal and external costs) working closely with the NBS CONEXTS Finance and customer representative

• Accountable for contributing to the development of Clinical Study Protocol, MAP/PTA/IIT treatment plan, amendments, Informed Consent Form and other study essential documents, and contributing to clinical sections of regulatory documents (Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, review of clinical trial application packages) as required; obtain approval from customer

• Responsible for Clinical Study Report either directly contributing to or managing the report writing, or by liaising with the T&MO or customer medical writing/narrative group to ensure report is completed according to current requirements

Minimum Requirements

Holzkirchen (near Munich)
Research & Development
Full Time

Senior Clinical Project Manager (d/f/m)

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