Careers
Lotus: Where Your Growth and Development = Our Success
Join the Lotus Clinical Research Team
Lotus Clinical Research seeks employees who are committed to excellence, quality, and the development of clinical research. We support our employees through professional and career development opportunities. We embrace a culture of openness, innovative thinking and deliberate decision makers. Join us today!
Available Positions
CRO Project Manager
Job Title: Project Manager-CNS
Job Status: Open to FT or Contractor candidates
Reports To: COO
Location: 100% Remote
About this 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. Under limited to no supervision, act as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service. This position will be part of the Clinical Operations Team, which is responsible for planning, executing, managing and closing projects associated with the company clinical study plans.
Responsibilities:
- Assumes primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
- Manages and executes the overall project scope, budget, and timelines. Identifies project success factors for analysis, reporting, and tracking.
- Manages resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements.
- 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).
- Serves as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
- Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device. Monitors adherence to project contract and budget.
- Coordinates with clinical, marketing, and operations management to identify goals and scope of clinical study projects. Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
- Supports the management and oversight of clinical study related vendors. Reviews site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements.
- Provide therapeutic training and guidance to clinical team.
- Attends off-site meetings and conferences, as needed.
Education and/or Experience:
- Bachelor’s degree or equivalent education/degree in life science/healthcare is required
- 5 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.
- CNS Project Management experience required
- CRO experience is highly preferred
- Experience qualifying & managing external vendors.
- Experience writing, reviewing and editing protocols and clinical study reports as well as working knowledge of the FDA submission process.
- Excellent organizational skills
- Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies. Strong written and verbal communication skills
CRO Director - Exec. Director of Rater Training
Job Title: Director, Sr. Director, or Executive Director of Rater Training and Scientific Solutions
Reports To: COO or President
Location: 100% Remote
Responsibilities:
- Create, execute, and proactively manage clinical trial processes related to clinical development and scientific services (Rater Training, Placebo Response Mitigation, Adjudication, Pre-Baseline Review Scientific Consultation, Publications, Scientific Content Creation, etc.).
- Provide input into all clinical development activities including integrated development plans specific to study protocols.
- Establish performance indicators to ensure successful execution of scientific services to agreed timelines.
- Represent scientific services and provide updates to the Leadership Team, Project Teams, and other key internal stakeholders.
- Lead and mentor Clinical Development staff to support successful internal training and
- professional development of staff.
- Oversee, plan, and implement Quality Checks to ensure high standards for compliance with company SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards.
- Develop and maintain strong relationships with sponsors, external experts, raters and Investigators
Education and/or Experience:
- MD, PhD, PsyD in psychiatry or psychology field preferred
- 3+ years’ experience conducting rating scale assessments in CNS clinical trials
- 3+ years of clinical trial experience
Skills and/or Abilities:
- Excellent organizational skills
- Strong written and verbal communication skills
- Exceptional attention to detail. Strong interpersonal skills
- Strong computer skills, including Microsoft Office
