Associate Specialist (m/f/d), Clinical Data Management GDO (CDMs)

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 4 people to join our Team as Associate Specialist (m/f/d), Clinical Data Management GDO (CDMs) to be based in our new office in Zürich, full-time and permanent. The start date is the 1st of September 2024.

 
Under the direction of the applicable management, the Associate Specialist (m/f/d), Clinical Data Management GDO 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: 

• 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: 
  

Education and Experience: 

• B.A. or B.S. degree completed or currently enrolled, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline. Will also consider some coursework (without completion) with relevant professional experience 

 
  

Knowledge and Skills: 

• Self-motivated, excellent in work planning, time management and multi-tasking 

• Fluent oral and written English skills 

• 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 (Tribschenstrass, 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. 

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.  
  

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

07/18/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.