Study Design Lead – Clinical Research, Central Labs Services

This is a fully remote position, open to applicants in United States.

📋 Description

• Interpret the requirements of sponsor protocols and convert them into a detailed, study-specific database design that guides the development of the Statement of Work for each CLS project.

• Utilize technical knowledge, therapeutic area insights, client understanding, and CLS processes to deliver a comprehensive and accurate database design for the CLS project.

• Maintain regular engagement with external clients throughout all stages of study design and development.

• Collaborate with internal departments to grasp organizational capabilities and assess the feasibility of client requests concerning study design.

• Act as a consultant on decisions related to study design, working alongside the Global Study Manager to identify potential risks and budget implications while providing advisory support at the program level.

• Coordinate internal processes and communications, which include feasibility assessments, material transfer agreements, and supply forecasting.

• Ensure that follow-up actions are integrated into both the database and the global monitoring plan.

• Conduct a comprehensive quality self-review.

• Document all client requirements associated with study design and verify that they are fully addressed.

• Oversee a diverse array of global and local studies with varying degrees of complexity.

⛳️ Requirements

• High School Diploma.

• A minimum of 7 years of professional experience in clinical or preclinical research.

• At least 1 year of experience working directly with clients and stakeholders.

• Familiarity with clinical or preclinical research protocols.

• Strong scientific understanding with an investigative and analytical mindset.

• Excellent planning, organizational, and problem-solving skills.

• Outstanding verbal and written communication abilities.

• Proven skills in relationship-building and management.

• Capable of effectively managing shifting timelines, changing priorities, and competing demands with clarity and discipline.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Short-term disability (STD).

• Long-term disability (LTD).

• 401(k) plan.

• Paid Time Off (PTO) or Flexible Time Off (FTO).

• Tuition Reimbursement.

• Employee Stock Purchase Plan.