Clinical Research Study Manager

Are you an experienced, passionate pioneer in technology? An industry solutions professional who wants to work in a collaborative environment. As an experienced Clinical Research Study Manager, you will have the ability to share new ideas and collaborate on projects as a consultant without the extensive demands of travel. If so, consider an opportunity with Deloitte under our Project Delivery Talent Model. Project Delivery Model (PDM) is a talent model that is tailored specifically for long-term, onsite client service delivery. PDM practitioners are local to project locations, minimizing extensive travel, and provides you with a full career path within the firm.

Work you'll do/Responsibilities

The Clinical Research Manager has the responsibility and accountability for daily functions and overarching management of the clinical study. This includes but is not limited to the following:

• Ability to manage multiple clinical research trials and ensure quality research conduct from study activation to study closure
• Manage communications with the CRO, subcontractors, and Sponsor
• Serves as an expert resource to coordinators in large scale and or multiple protocol clinical research studies
• Serve as a resource to facilitate development and implementation of tools, plans, and strategies to manage clinical trial portfolio and all monitoring activities
• Support BD in Proposals and Sales Opportunities
  • Support BD team with proposals development
  • Prepare and present during Sales Opportunity
  • Prepares reviews of incoming studies with man hours required, availability of patient population, staffing issues and financial compensation from the sponsor. This information will be presented to Leadership to determine if our sites should accept a clinical research study
• Support Study Start Up & Recruitment Activities
  • Responsible for submissions of study-specific regulatory documentation and review with IRB
  • Works with sponsors to develop an adequate budget for clinical trials, ensuring that the site is being compensated correctly for all clinical related procedures. Works with the finance, legal and risk team to negotiate budget and contracts
  • Ensure staff trainings and certifications are updated,
  • Supports Recruitment, based on capacity, location, and individual site capabilities
• Study Conduct & Close Out Activities
  • Manage study timelines to remain on schedule with deliverables and mitigate risk.
  • Works with study team to follow protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and implements corrective actions as appropriate
  • Maintain system and study specific trackers to ensure on-time milestone completion and project milestones (enrollment goals, database lock timelines, etc.) met in a timely manner
  • Develop and present project status reports to leadership and Sponsors/CROs
  • Escalate any risks to the Management and prepare mitigation plans to ensure project meet goals and objectives of the contract
  • Manage vendor relationships and communications to ensure smooth delivery of clinical trial services
  • Work with Finance team to support invoicing and resolve any billing inquiries
  • Liaise with Procurement and Site operations to ensure required infrastructure is in place and maintained for clinical trial activities and procure supplies as needed
  • Liaise with Quality and Partners for collaboration, performance, and quality of clinical trials
  • Ensure site and study close out procedures are following and arrange for data and documentation archive and storage
  • Train and Mentor new study managers and coordinators and provide training as necessary
• Quality & Regulatory Oversight
  • Oversee adherence to SOPs, Good Clinical Practice (GCP), FDA, and HIPAA regulations for all clinical trial staff members
  • Manage audits and monitoring visits across all clinical trials

• Adheres to and supports all federal regulations and university policies and procedures instituted to safeguard protected health information (PHI)
• Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with federal regulations and sponsoring agency policies and procedures. Assists PI to assure that all personnel complete appropriate training
• Cooperates with company compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office
• Performs other duties as assigned by management

• Bachelor's degree, preferably in Computer Science, Information Technology, Computer Engineering, or related IT discipline; or equivalent experience
• At least 3-5 years relevant experience in site based clinical research
• In-depth knowledge clinical trials and principles of Good Clinical Practices (GCP), protocol and study-specific operating procedures, consent forms, and study schedules
• Excellent written and verbal communication skills
• Superior interpersonal, organizational, problem solving and time management skills
• Capable of working independently with minimal supervision and high attention to detail as well as being able to work as part of a matrixed team
• Skilled with standard computer programs including the MS Office suit Effective skills in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
• Understanding of medical terminology as well as standard clinical procedures and protocols
• Ability to lift up to 20 pounds for a short period and capable of standing for extended periods of time
• Limited immigration sponsorship may be available

• Prior experience managing and mentoring staff members is preferred