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 detailed, study-specific database designs for CLS projects.

• Utilize technical knowledge, therapeutic area expertise, client insights, and CLS processes to produce comprehensive and accurate database designs.

• Collaborate with external clients throughout the study design and development phases.

• Work alongside internal departments to assess the feasibility of client study design requests.

• Provide guidance on study design decisions in conjunction with the Global Study Manager, taking into account risks and budgetary considerations.

• Organize feasibility assessments, material transfer agreements, supply forecasting, and associated communications.

• Integrate follow-up actions into the database and global monitoring plan.

• Conduct detailed quality self-reviews.

• Record and address all client study design specifications.

• Oversee a varied portfolio of global and local studies with diverse levels 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 directly interacting with clients and stakeholders.

• Familiarity with clinical or preclinical research protocols.

• Strong scientific insight with an investigative and analytical mindset.

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

• Outstanding verbal and written communication abilities.

• Demonstrated skills in building and managing relationships.

• Capability to manage changing timelines, shifting priorities, and competing demands.

• Bachelor’s degree in life sciences is preferred.

• Preferred: 2 or more years of experience working directly with clients and stakeholders.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Short-term disability (STD).

• Long-term disability (LTD).

• 401(k).

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

• Tuition Reimbursement.

• Employee Stock Purchase Plan.