Job Description

About the Opportunity

Cleerly is seeking a Project Manager with at least one year of clinical research experience,
preferably at a top academic medical center or clinical Contract Research Organization. You will
be responsible for planning, organizing, communicating, implementing and evaluating team
objectives and will serve as the point of contact for sponsors. This is a unique opportunity to
participate in groundbreaking innovative research and actively shape a dynamic field in
medicine.

 

About the Team

The Clinical Trials Solutions Unit (CTSU) is a division of Cleerly’s Scientific Affairs team. We
are a team of experienced trialists with diverse backgrounds working on exciting care
transforming clinical, national, and international clinical trials. Most of us are based in the NYC
area, and work partially onsite at our office on Roosevelt Island.

 

Salary: $88,000 - $100,000*

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable
pay, commission, bonuses, etc.). We hire employees anywhere within the United States and
account for geography when determining base salary.

 

Responsibilities

• Supports day-to-day operations of multiple clinical trials, including trial start-up, conduct,
  and closeout activities;
• Supports the development of project related deliverables including the project
  management plan, overall budget, study timeline, risk management / contingency plan,
  monitoring plan, communication plan, etc.
• Perform administrative tasks such as organizing and scheduling meetings, training and
  retreats, including preparing agendas and managing logistics. Additionally, facilitate
  urgent day-to-day communications with clinical sites.
• Supports the development of trial specific guidance documents that align with Cleerly’s
  and sponsors’ expectations;
• Participates in project team meetings;
• Ensures compliance with Research Core Lab policy, procedures and SOPs, GCP, and
  local, regional and federal regulations;
• Maintains a high level of professional expertise through familiarity with clinical literature;
• Performs additional duties as assigned.

Requirements

• Bachelor’s degree, preferable in medical or life sciences field with 1-2 years of related
  clinical research experience in a pharmaceutical, medical device, or CRO environment
  with experience in cardiology preferred;

• Previous project management experience, preferred;

• Proficient with Microsoft Outlook, Word, MS Project and Excel;

• Ability to analyze information and solve problems relating to information gleaned from
  Case Report Forms (CRFs);

• Knowledge of GCP/ICH guidelines and FDA regulations;

• Understanding of drug development and medical device process;

   

• Must possess excellent communication and writing skills, patience, professionalism and
  ability to effectively interact with staff and management alike. Ability to verbally
  communicate effectively with department heads, medical leadership and other team
  members;
• Ability to multi-task and interface with users who are working under deadlines. Ability to
  set priorities with excellent time management skills. Ability to accurately project time to
  complete tasks and communicate this information effectively to project teams. Must have
  the flexibility and willingness to occasionally work evenings and weekends in order to
  meet research trial deadlines;
• Experience and/or knowledge of US and OUS regulatory aspects of clinical research
  including IDE and IND submissions, adverse event reporting, Good Clinical Practices,
  Good Documentation