Manager, Site Start Up

Precision Value & Health; United States; Remote; USD 110,000 - 167,000; Full time

Job summary

A leading health consulting company is seeking a Manager for Site Start Up to oversee daily SSU activities and ensure compliance with quality standards. The ideal candidate will manage personnel development, inter-departmental communication, and resource allocation. This remote role requires substantial clinical research experience and strong leadership skills. Compensation includes a salary range of $110,700—$166,100 USD, along with various employee benefits.

Benefits

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off for sick leave and vacation

Discretionary annual bonus

Qualifications

• 6 years in clinical research with extensive Site Start-up experience.
• Demonstrated knowledge of GCP/ICH guidelines.
• Experience with resource management in a team environment.

Responsibilities

• Manage SSU personnel and ensure quality standards.
• Coordinate inter-departmental and client communications.
• Contribute to development of training plans and standards.

Skills

Leadership

Communication

Organizational Skills

Analytical Skills

Team Management

Education

Bachelor's degree in life sciences or related field

Tools

Microsoft Office Suite

Clinical software (CTMS, eTMF, EDC)

Job description

17 hours ago Be among the first 25 applicants

Position Summary

Manages and oversees the day-to-day activities Site Start-up (SSU) personnel in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study specific plans with an emphasis on effective resourcing and development of personnel. Provides oversight and leading activities for site start up project delivery; coordinates inter-departmental and client communication and helps resolve administrative, personnel, and project issues.

Manager, Site Start Up -

Location: Remote Remote United States

Remote Remote United States

Job Type: regular full-time

Division: Precision for Medicine

Business Unit: Clinical Solutions

Requisition Number: 5641

Position Summary

Manages and oversees the day-to-day activities Site Start-up (SSU) personnel in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study specific plans with an emphasis on effective resourcing and development of personnel. Provides oversight and leading activities for site start up project delivery; coordinates inter-departmental and client communication and helps resolve administrative, personnel, and project issues.

Essential functions of the job include but are not limited to:

• Develop, mentor, manage and coach SSU personnel to ensure Precision’s quality standards are maintained.
• Advocate individual career development, and individual responsibility/accountability
• Maintain routine 1:1 meetings with SSU personnel for management of assigned tasks and career development
• May serve as SME support for Site Start up activities.
• Ensure SSU personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
• Ensure that SSU personnel have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
• Contribute to development of training plans and hold SSU personnel accountable to achieving training goals or addressing training needs
• Ensure SSU personnel are in compliance with administrative tasks (i.e., time entry, corporate-level training, time/billing compliance and travel expense and expense reporting compliance, as applicable)
• Participate in the interview process for new SSU personnel by conducting CV review and participating in the interviewing process.
• Support on-boarding training for new SSU personnel in conjunction with Human Resources, Training and other functional areas
• Contribute to development of robust standards and processes for the staff and ensure consistent, quality execution among the SSU personnel
• Active participant in resourcing of SSU personnel and manage FTE allocation per project to ensure time/work billed is in alignment with project budget and assumptions, with continued assessment and adjustment as needed
• Provides on-going feedback, development and coaching of line reports including annual performance reviews
• Active participant in planning and conducting department meetings to provide routine high-level communication to SSU personnel
• Assists with internal initiatives
• Performs other duties as assigned by management
  
  

Qualifications

Minimum Required:

• Bachelors degree in life sciences or related field or equivalent combination of education, training, and experience.
• A minimum of 6 years in clinical research including extensive experience of Site Start-up
• Leadership experience or proven competencies for this position.
• Demonstrated knowledge of GCP/ICH guidelines and the clinical development process.
  
  

Other Required

• Demonstrated competence in people management
• Experience working in team environment with resource management experience
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc)
• Strong communication and interpersonal skills to effectively interface with others in a team setting
• Strong organizational skills, attention to detail, and a customer service demeanor
• Proven experience in strategic planning, risk management and change management
• Fluency in English.
  
  

Preferred

• Advanced degree in life sciences or related field
• Experience in CRO environment
  
  

Competencies

• Ability to work closely with business unit leadership to understand customer's needs
• Demonstrated analytical skills and business acumen
• Strong presence withAbility to confidently deliver presentations internally or for clients
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective.
• Ability to lead and inspire excellence within a team
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Proven ability to effectively influence, negotiate, and manage conflict
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Strong presentation, verbal and written communications skills
• Occasional travel may be required.
  
  

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$110,700—$166,100 USD

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Apply Now

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management and Information Technology

• Industries

  Business Consulting and Services

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