Clinical Data Management Specialist – Intern

Data: 2018-12-06

Location: Warsaw, PL

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Requisition ID: CLI008161

Have you heard about MSD? 


 

MSD is an innovative, global healthcare leader committed to improving health and well-being in 140 countries around the world. We continue to focus our research on conditions that affect millions of people around the world - diseases like Alzheimer's, Diabetes and Cancer - while further expanding our strengths in areas such as vaccines and biologics.

We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow. 

 

 

MSD’s Global Human Health (GHH) Division abides by a “patient first, profits later” ideology. Results-driven and ambitious, this team of individuals represents a functional balance between meeting company objectives and the needs of people around the world. The division is comprised of sales and marketing professionals who are passionate about their role in bringing MSD's prescription medicines, vaccines, and other medical products to our customers worldwide.


Opportunity we offer :

 

Under the direction of the applicable management and supervision of a CDM/SCDM/LCDM in assigned trials, the CDM - Intern is supporting CDM/SCDM/LCDM in executing end to end data management activities pertaining to clinical trials, focusing on: data entry (if applicable), data integrity review and reconciliation, query management, and database lock preparation (if applicable), in compliance with MSD Standard Operating Procedures (SOPs) and ICH-GCP guidelines..

 

Primary activities, include, but are not limited to:

 


  • Performs Sponsor Data Entry as applicable per data management plans following entry guidelines.

  • 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.

  • Escalates overdue items, including but not limited to outstanding questions and missing visits and reports the outstanding items status to the CDM/SCDM/LCDM.

  • Assists the CDM/SCDM/LCDM with data management activities to ensure all identified data issues are resolved prior to study database lock.

  • Ensures compliance to standard key performance indicators according to process expectations at the protocol level.

  • Monitors data quality and cycle-time performance measures to ensure compliance, performs root cause analysis and implements action plans as needed.

  • Proactively communicates with CDM/SCDM/LCDM to share project status, risk assessment and outstanding item resolution status.


  • May temporary support other E2E Data Management activities under the guidance of the CDM/SCDM/LCDM of the trial if defined as needed.

 

Qualifications

Expected Qualification of YOURS :


 

Education:


  • B.A., B.S. degree or students’ status for the master’s degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

 


Knowledge and Skills:




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


  • 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.

 


 


We offer:




  • Competitive remuneration


  • Position in a leading global healthcare company


  • Challenging career


  • Professional growth based on performance

 
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

 



Job: Clinical Data Management
Other Locations:
Employee Status:
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

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