Senior Clinical Data Manager

Insmed

5+ years

$100,000.00 to $139,133.00 per year

Bridgewater

10 July 3, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Data Manager

External ID: R1490
Job Function: Clinical Development
Salary Range: $100,000.00 to $139,133.00 per year
Location: Bridgewater, NJ, USA

Company Description:

Insmed is a global biopharmaceutical company committed to transforming the lives of patients with serious and rare diseases. We prioritize a patient-first mentality and value our employees as our most valuable resource. Our team is driven to challenge the status quo, solve problems, and work collaboratively with urgency and compassion.

Guided by core values of collaboration, accountability, passion, respect, and integrity, we strive to create an inclusive, diverse, and flexible work environment. Our employees are recognized for their dedication and willingness to take initiative. If you share our vision and want to work with the most dedicated people in the biopharma industry, join Insmed to accelerate your career.

Recognitions:

Named Science’s Top Employer in 2021, 2022, and 2023
Certified as a Great Place to Work in the U.S. for the third consecutive year in July 2023
Listed among the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™

Overview:

The Senior Clinical Data Manager is responsible for the direct management and oversight of data management activities for assigned studies. This role involves ensuring 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. Note that this is not a supervisory position.

Responsibilities:

Serve as the primary point of contact between Data Management and the clinical team.
Author, review, and revise Data Management study plans (Data Management Plan, Data Validation Plan, Data Review Plan, CRF Completion Guidelines, etc.) to ensure quality and standardization.
Approve and authorize DM deliverables, including finalized DM documents, database release to production, and database lock.
Collaborate with vendors to support DM tasks such as data transfer.
Manage the design and development of eCRFs, including database UAT.
Oversee the development and implementation of edit check specifications and work with database programmers during programming and validation.
Lead DM study meetings, distribute agendas, and create minutes capturing action items and decisions.
Conduct data reviews with the clinical team to ensure accuracy, consistency, and reliability.
Review database metrics and follow the escalation process to resolve issues.
Collaborate with the study team to ensure study databases are locked based on pre-defined criteria and timelines.
Ensure CDM procedures and processes meet business requirements and are consistently adhered to.
Provide high-quality services through efficient and compliant processes.

Position Requirements:

Minimum of five years of clinical data management experience in a biotech, pharmaceutical, or CRO environment (or equivalent).
Bachelor’s degree in a 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 (Medidata Rave desired) and ad hoc query tools (JReview, others desired).
Experience in CRO and vendor management.
Experience with multiple trial phases of clinical development.

Salary Range:

The base salary range for this position is from $100,000.00 to $139,133.00 per year. Insmed considers a combination of education, training, experience, scope, complexity, and market and internal value when determining salary levels for potential new employees.

Compensation & Benefits:

We invest in our team members' total well-being, offering a competitive total-rewards package globally, including:

Flexible work arrangements
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 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 online 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.

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Senior Clinical Data Manager

Job Description

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