Clinical Research Scientist

3+ years

$147,000.00 to $206,333.00 per year

Remote, USA

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

Clinical Research Scientist

External ID: R1490
Job Function: Clinical Development
Salary Range: $147,000.00 to $206,333.00 per year
Location: Bridgewater, NJ, USA

Company Description:

Insmed is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. We value our employees as our most precious resource, driven by a patients-first mentality. Our team consists of talented individuals from around the world who 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 foster an inclusive, diverse, and flexible work environment where employees are recognized for their dedication and initiative. If you share our vision and want to work with the most committed professionals 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 Clinical Research Scientist (CRS) supports and works predominantly with the Medical Monitor for assigned protocols and projects, collaborating with vendors and cross-functional teams. The CRS provides scientific support to clinical development, operations, regulatory, and quality assurance teams, ensuring adherence to all standard operating procedures (SOPs).

Responsibilities:

Collaborate with internal teams, CROs, and external vendors to prepare, review, and finalize clinical protocol documents.
Contribute to the scientific and operational aspects of protocol development and execution from study design planning through final reporting.
Provide scientific input and review of protocol data, support in assessing medical monitoring reports, study integrity/conduct, and protocol oversight.
Support the preparation of abstracts, manuscripts, presentations, and materials for meetings related to the protocol and program.
Provide protocol-level scientific review to support regulatory document development (IND submissions, IND Annual Updates, DSUR, Investigator Brochures, briefing books) and aid in responding to regulatory authorities.
Assist with enrollment projections and the development and implementation of subject recruitment and retention strategies.
Provide scientific support to study teams, including data management activities, database lock processes, and review of data, medical monitoring, and query resolution.
Collaborate with medical monitors and drug safety vendors to review adverse events.
Review statistical analysis plans and provide scientific input.
Support the development, review, and revision of departmental and corporate SOPs and processes.
Provide clinical development and technical expertise for due diligence activities.
Support regulatory activities at the protocol level.

Qualifications:

Pharm.D., Ph.D., or M.D. with a minimum of 3 years of drug development experience, particularly in Phases I-II.
Knowledge of pharmacokinetic applications related to drug disposition.
Strong medical writing and presentation skills.
Understanding of biostatistics and data management.
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents.
Excellent written and oral communication skills.
Ability to work in a high-paced environment.
Demonstrated team-building skills and the ability to work successfully in a matrix team environment.
Analytical, negotiation, meeting management, cross-functional team, and leadership skills.
Experience with EDC systems, with a preference for RAVE and J-Review.
Strong conflict management, time management, and organizational skills.
Travel requirement approximately 5-10% based on protocol development stage and program needs.

Salary Range:

The base salary range for this position is from $147,000.00 to $206,333.00 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.