Study Design Lead

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

📋 Description

• Accurately interpret and convert sponsor protocol requirements into a protocol-specific database to produce a Statement of Work for the CLS project.

• Utilize technical, therapeutic area, client, and company-specific process expertise to deliver a thorough and effective database design.

• Regularly engage with external clients throughout all duties and responsibilities.

• Collaborate with internal departments to grasp the full range of company capabilities and evaluate the feasibility of requests to fulfill client needs regarding study design.

• Serve as a consultant to guide on study design decisions and collaborate with the Global Study Manager (GSM) to identify risks and budget implications related to study design.

• Enhance consultancy capabilities at the study program level.

• Exhibit strong interpersonal and communication abilities to foster robust internal and external relationships, ensuring high-quality study design.

• Oversee internal processes and communications concerning study design and ensure that follow-ups are integrated into the database and global monitoring plan.

• Conduct quality self-reviews.

• Guarantee that all customer requirements related to study design are documented and addressed.

• Operate effectively in an environment with shifting timelines and priorities.

• Demonstrate appropriate self-organization and the ability to manage competing priorities.

• Participate in functional meetings and contribute input, ensuring processes remain current.

• Adhere to our internal Central Lab Global Project Management strategy.

• Manage a portfolio of global and local studies with varying degrees of complexity.

• Foster a culture of continuous improvement, quality, and productivity.

⛳️ Requirements

• Bachelor’s degree in a life science.

• 6 or more years of experience in the clinical research industry or in a laboratory setting.

• Experience working directly with internal or external clients.

• Strong skills in relationship building and management.

• Familiarity with clinical or preclinical research protocols.

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

• Outstanding verbal and written communication skills.

• Proficient in computer applications (e.g., Windows, Excel, Word).

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Professional development.