Senior Clinical Data Manager

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

Named Science's Top Employer in 2021, 2022, and 2023

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 were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.

  

 

 

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

  

 

Overview

Responsible for the direct management and oversight of data management activities for assigned studies. Work in conjunction with the study team to ensure data review, project support, study document management and oversight of DM timelines, EDC/IWRS setup, study database design, Clinical Data capture, discrepancy management and data reconciliation. This is not a supervisory position.

Responsibilities

• Primary point of contact between Data Management and the clinical team with respect to the management and oversight of data management activities
• Author, review/revise Data Management related study plans including Data Management Plan, Data Validation Plan, Data Review Plan, CRF Completion Guidelines and other study documents to ensure quality and standardization
• Collect approvals and provide authorization on DM deliverables including but not limited to finalized DM documents, database release to production and database lock
• Work with vendor(s) particularly to support the DM tasks such as transfer of data
• Manage design and development of eCRFs, including database UAT
• Oversee and manage the development and implementation of edit check specifications and work with database programmers during programming and validation
• Manage and oversee data management related activities for the ongoing study
• Lead DM study meetings; distribute agenda, create minutes capturing action items and decisions
• Lead data reviews with clinical team to ensure accuracy, consistency and reliability of data
• Review database metrics and follow escalation process to achieve resolution of noted issues
• Collaborate with study team to ensure study databases are locked based on pre-defined criteria and timelines
• Ensure that CDM procedures and processes meet business requirements and are adhered to in a consistent manner
• Provide high quality services through efficient and compliant processes

Position Requirements (Required and/or Preferred Skills, Experience and Education):

• Minimum five years of Clinical Data management experience in a biotech, pharmaceutical or CRO environment (or equivalent)
• Bachelor's Degree in scientific or technical discipline
• Experience with all aspects of DM including Database Build, Study Startup, Study Conduct and Database Closure activities
• Hands on experience with Electronic Data Capture systems required (current Medidata Rave desired) and ad hoc query tools required (JReview, other desired)
• Experience in CRO and vendor management required
• Experience with multiple trial phases of clinical development

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.
The base salary range for this job is from $100,000.00 to $139,133.00 per year

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus 
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break 

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

Applications are accepted for 5 calendar days from the date posted or until the position is filled.