Clinical Data Manager

Job Description

Our company is building a Shared Service Center in the heart of Philadelphia and seeking passionate, detail orientated individuals to join our Clinical Data Management team. This position includes paid training and a comprehensive benefits package.

The Clinical Data Manager (CDM) is responsible for activities pertaining to end-to-end data management of 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, and database lock preparation, in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.  

Primary activities include, but are not limited to:

• Performs data entry following relevant guidelines.

• Runs data integrity check reports in accordance with data review plan and relevant SOPs.

• Completes trial level archiving activities including, but not limited to, filing of essential documentation.

• Supports inspection readiness via ongoing reconciliation of essential documents.

• Supports other document management tasks (via MS Office).

• May support other CDM tasks as necessary.

• Creation and management of Paper Case Report Form (CRF) inventory tool.

• Escalations of overdue items, including outstanding questions and missing visits.

• Review of basic standard reports.

• Quality Control of Data Review Plan (DRP) and report run package.

• Participates in the development and implementation of change request activities.

• Raises questions to, reviews responses from, and corresponds with stakeholders and customers.

• Completes user acceptance testing of data management tools.

• Completes assigned data management activities in support of database lock.

• Maintains compliance with standard key performance indicators.

• Monitors data quality and cycle-time performance measures, performs root cause analysis and implements action plans.

• Proactively communicates with team members to share project status, risk assessment and outstanding item resolution status.

• Supports training and mentoring as needed (includes creation and updates of training content).

Education and Experience:  

• High School Diploma (or equivalent). 

Requirements:  

• Basic knowledge of MS Office – Word/Excel/Outlook  

• Ability to commute onsite 5 days/week (M-F)   

• Experience working with sensitive/confidential documents preferred 

• Proven work experience preferred

Competencies: 

• Must have written and verbal English skills 

• Demonstrated ability to manage different deliverables at the same time (i.e. multitasking, organizational skills) 

• Team player 

• Strong & proven work ethic 

• Attention to detail 

• Self-motivated 

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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. 

Who we are …

We are known as Merck & Co., Inc., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. MSJR

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R186260