Job description

Remote Project Manager

Why Join Us?

Lotus is a reputable, collaborative Clinical Research Organization that will guide you in your career. Lotus offers career development, leadership opportunities, and encourages our employees to meet their personal and career goals. As a smaller organization, we ensure a cooperative environment where individual voices and contributions make a difference and are valued. We offer a competitive salary based on experience and a range of benefits including medical, dental, vision, 401k, and PTO.

P*urpose of the Role: *

The Project Manager is a proven leader in clinical program management in the clinical research industry, and manages, executes and reports on clinical study operations. This position provides leadership and support to members of the multidisciplinary project team, internally and externally. Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, and project deliverables.

Job Responsibilities:

• Assumes primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities. Manages the project scope.
• Leads the development of study specific protocols, consent forms, and other trial related materials as required.
• Ensures the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
• Participates in the review of clinical data for analysis
• Ensures that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).
• Plans for and manages all materials to support the appropriate execution of the clinical projects, including, distribution of documents, forms, supplies, equipment, and investigational device.
• Coordinates with clinical, marketing, and operations management to identify goals and scope of clinical study projects.

Education/Experience:

• Bachelor’s degree or equivalent education/degree in life science/healthcare is required
• At least 1 year of working within clinical project management at a pharmaceutical company, or CRO..
• Experience qualifying & managing external vendors.
• Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies.

*

• Experience writing, reviewing and editing protocols and clinical study reports as well as working knowledge of the FDA submission process.

Skills:

• Ability to facilitate a teamwork philosophy with a positive attitude.
• Extensive organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives.
• Extensive experience overseeing and coordinating the work of others.
• Ability to work effectively and efficiently handling multiple tasks simultaneously, thus managing multiple deadlines.
• Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
• Strong desire to take ownership of many different projects.
• Strong computer skills, including Microsoft Office.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Preferred)

Experience:

• Project management: 1 year (Required)
• Clinical Research Organization (CRO): 1 year (Required)

Work Location: Remote

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