Study Design Lead – Clinical Research, Central Labs Services

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

📋 Description

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

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

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

• Collaborate with internal teams to comprehend organizational capabilities and assess the feasibility of client study-design requests.

• Provide consultation on study-design choices and work alongside the Global Study Manager to pinpoint risks and budget considerations.

• Oversee feasibility assessments, material transfer agreements, supply forecasting, communications, and follow-up actions.

• Integrate requirements into the database and global monitoring plan while performing quality self-reviews.

• Record all client study-design requirements and confirm their incorporation.

• Manage a varied portfolio of global and local studies with differing 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 working directly with clients and stakeholders.

• Strong scientific understanding with an investigative and analytical approach.

• Self-motivated individual capable of independently identifying and acquiring necessary information.

• Knowledge of clinical or preclinical research protocols.

• Strong skills in planning, organization, and problem-solving.

• Excellent verbal and written communication abilities.

• Demonstrated skills in building and managing professional relationships.

• Proficient in handling changing timelines, evolving 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.