|Lieu de travail||***CH Suisse/ Schweiz/ Switzerland***, 8004 Zürich|
|Expérience professionnelle réquise||non|
|Description complète||We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.|
We are currently looking for a Team of Clinical Data Managers (CDMs) to be based in our new office in Zürich. (full-time, indefinite).
Under the direction of the applicable management, the Clinical Data Manager is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with our company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:
Receives the study related paper documents (i.e. patient diary, adjudication, etc.) from sites or other functional areas, registers them into a work management tool and transfers to data enterer for processing
Performs Sponsor Data Entry as applicable per data management plans following entry guidelines
Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the SCDM/LCDM
Runs data integrity check reports in accordance with data review plans and relevant SOPs.
Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution
Responsible for the execution of user acceptance testing of data management tools under the guidance of the SCDM/LCDM
Escalates overdue items, including but not limited to outstanding questions and missing visits
Assists the Senior/Lead CDM with data management activities to resolve all identified data issues prior to study database lock
Complete trial level archiving activities under the direction of the SCDM/LCDM including, but not limited to, filing of essential documentation
Maintains compliance with standard key performance indicators according to process expectations at the protocol level
Monitors data quality and cycle-time performance measures to maintain compliance, performs root cause analysis and implements action plans as needed
Proactively communicates with Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status
B.A. or B.S. degree completed or currently enrolled, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline
Self-motivated, excellent in work planning and time management
Fluency in English (oral and written)
Good sense and awareness of regulations and policies
Able to work under pressure and in a changing environment with flexibility
Good communication skills with the ability to communicate with both the technical and business areas
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.
We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.
The recently opened new location in Zurich focuses on accelerating research, data and commercialization of our medicines and vaccines. The new office will be staffed by teams working in strategic and operational roles in medical affairs, clinical development, access and marketing operations functions. The new location has a target date of 2021 for operational readiness.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.