Clinical Research Specialist

1 week ago

Bridgewater, New Jersey, United States Insmed Full time
Company Overview


Insmed is a global biopharmaceutical organization dedicated to improving the lives of patients affected by serious and rare diseases.

Our employees are our greatest asset, and our actions are driven by a commitment to a patients-first approach.

We strive to expand our team with skilled professionals from around the globe who are eager to challenge conventional methods, solve complex issues, and collaborate with urgency and empathy.

Rooted in our core values of teamwork, accountability, passion, respect, and integrity, we aim to cultivate an inclusive, diverse, and adaptable workplace where our employees are acknowledged for their dedication and hard work.

If you align with our vision and aspire to work alongside the most committed individuals in the biopharmaceutical sector, consider joining Insmed to enhance your career.

Recognitions


Insmed has been recognized as one of Science's Top Employers in 2021, 2022, and 2023, reflecting our commitment to fostering a collaborative environment where our team can excel.

Each day, our employees channel their enthusiasm for science and research into groundbreaking solutions for patients, which is why we have been named the top company to work for in the biopharmaceutical industry in Science's Top Employers Survey for three consecutive years.A Certified Great Place to Work

We believe our organization is truly exceptional, and our employees concur. Insmed has achieved Great Place to Work certification in the U.S. for the fourth consecutive year.

We are also proud to be featured on various prestigious lists, including 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.

Position Overview


The Clinical Research Specialist (CRS) will primarily collaborate with the Medical Monitor for designated protocols and/or projects, engaging with vendors and cross-functional teams.

The CRS will deliver scientific support to clinical development and operations, regulatory, and quality assurance teams, ensuring compliance with all standard operating procedures (SOPs).

Key Responsibilities


The CRS will participate in cross-functional teams to design and implement Clinical Study protocols within clinical programs. Responsibilities include, but are not limited to:

  • Collaborating with internal teams, CROs, and external vendors to prepare, review, and finalize clinical protocol documents.
  • Contributing to the scientific and operational aspects of protocol development and execution from study design to final reporting.
  • Providing scientific input and reviewing protocol data, supporting the assessment of medical monitoring reports, study integrity, and protocol oversight.
  • Assisting in the preparation of abstracts, manuscripts, presentations, and materials for meetings related to the protocols and programs.
  • Conducting protocol-level scientific reviews to support the development and updates of regulatory documents (e.g., IND submissions, IND Annual Updates, DSUR, Investigator Brochures).
  • Supporting enrollment projections and aiding in the development and implementation of subject recruitment and retention strategies.
  • Providing scientific support to study teams, including collaboration in the review and development of Data Management activities.
  • Participating in data review, database lock, medical monitoring, and query resolution for the protocol.
  • Working with medical monitors and drug safety vendors to support and review adverse events scientifically.
  • Reviewing statistical analysis plans and supporting corporate objectives.
  • Developing, reviewing, and revising departmental and corporate SOPs and processes.
Qualifications


The ideal candidate will possess a Pharm.D., Ph.D., or M.D. with a minimum of 3 years of experience in drug development, particularly in Phases I-II. Additional qualifications include:

  • Knowledge of pharmacokinetic applications related to drug disposition.
  • Strong medical writing and presentation skills.
  • Understanding of biostatistics and data management.
  • Ability to analyze and interpret scientific and technical journals, financial reports, and legal documents.
  • Excellent written and verbal communication skills.
  • Capacity to thrive in a fast-paced environment.
  • Demonstrated team-building skills and the ability to work effectively in a matrix team environment.
  • Analytical, negotiation, meeting management, cross-functional team, and leadership skills.
  • Experience with EDC systems, particularly RAVE and J-Review, is preferred.
  • Strong conflict management, time management, and organizational skills.
Travel Requirements


Travel is required approximately 5-10% based on protocol development stages and program needs.

Salary Range


Insmed considers a combination of education, training, experience, and the position's scope and complexity when determining salary levels for potential new employees. The base salary range for this position is from $147,000.00 to $206,333.00 per year.

Compensation & Benefits


We are committed to investing in the total well-being of every team member, both now and in the future. We offer a competitive total-rewards package to all employees globally, including:

  • A flexible approach to work location and schedule.
  • A competitive compensation package, including bonuses.
  • Stock options and RSU awards.
  • Employee Stock Purchase Plan (ESPP).
  • A flexible vacation policy with a generous paid holiday schedule.
  • 401(k) plan with company match.
  • Medical, dental, and vision plans.
  • Company-provided life and accidental death & dismemberment insurance.
  • Short and long-term disability benefits.
  • Unique offerings of pet, legal, and supplemental life insurance.
  • Flexible spending accounts for medical and dependent care.
  • Employee Assistance Program (EAP).
  • Mental health online resources.
  • Well-being reimbursement.
  • Paid leave benefits for new parents.
  • Paid time off for volunteering.
  • On-site fitness center at our 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, as the company 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 has been established.

Applications are accepted for a limited time from the date posted or until the position is filled.

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