Clinical Data Manager, GDO

  • MSD
  • Zürich, ZH, Switzerland
  • 07/03/2020
Full time Data Science Data Analytics Big Data Data Management

Job Description

Job Description

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

QUALIFICATIONS:

  • 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.

THE COMPANY…

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 …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

INVENT.
IMPACT.
INSPIRE.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Shift:

Valid Driving License:

No

Hazardous Material(s):

Requisition ID:R43143