Sr. Clinical Trial Manager

Clinical Trial Manager - CTM

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional. As a Clinical Trial Manager (CTM) / Sr. Clinical Trial Manager (Sr. CTM), you will be responsible for acting as a central contact for the clinical study team(s) and assist with the execution and clinical trial CTM Responsibilities (will also need to meet the General Responsibilities):

Sr. CTM Responsibilities (will need to meet all responsibilities [General and CPM]):

• 
  Identify, engage, and manage the activities of contract research organizations (CROs) and other clinical trial vendors (e.g., Interactive Response Technology (IRT), imaging vendor, central labs, etc.) as well as serve as liaison between internal team members, investigative sites, and CROs.
  
• 
  Support the study lead in the management of clinical study timelines and budget by utilizing appropriate project management tools, identify and select vendors, manage vendor contracts and ensure budgets are within department guidelines.
  
• 
  Co-lead team meetings and collaborate with cross-functional groups within the clinical study team (e.g., Clinical Data Science, Clinical Development, Pharmacokinetics, Regulatory, etc.) to achieve clinical trial goals.
  
• 
  Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.
  
• 
  Assess adequacy/feasibility of potential clinical investigators and sites, including qualification of investigators, evaluation of facilities, personnel, patient referral base, and adherence to GCP.
  
• 
  Review and identify trends when performing routine data surveillance of data listings, and support in the preparation of interim and final Clinical Study Reports and resolution of data discrepancies.
  
• 
  Provide support, mentorship, guidance, and direction to Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs), as appropriate.
  
• 
  Actively contribute in development of internal business documents (e.g. SOPs, Clinical Study Reports, Investigational New Drugs (INDs), New Drug Applications (NDAs), and other Clinical, Regulatory, Safety documents) with minimal supervision.
  
• 
  Support other Clinical Operations activities as appropriates.
  

Required Skills, Experience and Education:

• 
  RN or Bachelor’s degree in biological sciences or health-related field required.
  
• 
  5+ years (CTM) or 7+ years (Sr. CTM) direct experience preferred and/or relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
  
• 
  Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
  
• 
  Experience in selection of CROs/vendors and management of external resources.
  
• 
  Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  
• 
  Excellent written/verbal communication and interpersonal skills.
  
• 
  High sense of priority and commitment to excellence in the successful execution of deliverables.
  
• 
  Ability to analyze operational data, perform with an emphasis on quality, timeliness and multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
  
• 
  Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  
• 
  Travel may be required (~15%).
  

Preferred Skills:

• 
  Decision-making skills
  
• 
  Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
  
• 
  Oncology experience, early and/or late stage, strongly preferred.
  
• 
  Knowledge and/or familiarity with EMEA/APAC region(s) clinical trial operations.
  
• 
  Attention to detail.