Clinical Data Manager, Clinical Data Management

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

Conduct Data Management (DM) activities for assigned studies in support of DM study lead and clinical study team. Complete assigned tasks in compliance with company processes, GCP and regulations across all study phases including but are not limited to document development and maintenance, UAT testing, reviewing data, discrepancy management, reconciliation, development and generation of data listings, tracking issues, performing database QC, and managing DM documents in the trial master file.

Responsibilities

• Provide input on Data Management (DM) related study plans including Data Management Plan (DMP), Data Validation Plan, Data Review Plan, CRF Completion Guidelines, and other study documents to ensure quality and standardization; may be responsible for updating DM documents to ensure they are up to date
• Contribute to development of initial and updated eCRF designs, including database UAT
• Assist in the development of global library standards and align with the global library process
• Contribute to development and implementation of edit check specifications and work with database programmer on edit check development and validation
• Facilitate transfer of data from external vendors, which may include finalizing Data Transfer Agreement/ Specifications and verifying test data per specifications document
• Work with internal programmers to develop ad hoc SAS listings, patient profiles, and other outputs
• Run and review outputs and database study metrics; identify discrepancies to assist in data cleaning
• Participate in data reviews with clinical team to ensure accuracy, consistency, and reliability of data
• Review discrepancies in EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines; note and communicate trends to clinical trial manager(s) for follow-up
• Facilitate identification and capture of Protocol Deviations, if applicable
• Reconcile external data to clinical study database and perform Serious Adverse Event reconciliation
• Work with study teams to ensure study databases are locked based on pre-defined criteria and established timelines
• Ensure DM procedures and processes are adhered to in a consistent manner
• Provide high quality services through efficient and compliant processes

Position Requirements:

• No less than 3 years of clinical data management experience in a biotech, pharmaceutical, or CRO environment
• Associates Degree or higher is required, Bachelor Degree is preferred
• Experience with DM activities including Database Build, Study Startup, Study Conduct, and Database Closure
• Hands on experience with EDC systems required (current Medidata Rave desired) and ad hoc query tools required (JReview, other desired)
• Experience in CRO and vendor management desirable
• Experience with multiple phases of clinical development highly desirable

Salary Range

39-52

Compensation & Benefits

At Insmed, we’re committed to investing in