We are looking for a Manager of Site Operations to join our team!
Are you someone who can provide excellent leadership, is well-organized and adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
This role is ideal for an individual who can motivate cross functional internal and external teams to collaboratively work together to produce the best quality outcome and foster positive relationships.
In this position you will:
- Supervise team members within Site Operations including Clinical Research Associates (CRAs) and Clinical Trial Managers (CTMs). Work with each team member to set clear job expectations, assess training needs and ensure team members receive training as needed.
- Assist team members to develop personal and organizational improvement and innovation goals with periodic reviews.
- Develop and manage multidisciplinary project team activities. Assess project issues and propose resolutions to the project team, CPC executives and/or the Sponsor.
- Provide monthly status reports to the Director, Clinical Research Operations on all staff, key performance indicators, timelines and deliverables as necessary.
- Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Site Operations based on individual employee, functional area and project metrics.
- Provide strategic input into innovations and contribute to the achievement of functional area goals.
- Oversee deliverables to ensure timely completion and high quality production in compliance with applicable policies, standard operating procedures (SOPs), work instructions (WIs) as well as applicable regulations and guidelines.
- Work with the Director, Clinical Research Operations on evaluating functional area, personnel and productivity metrics to assess and implement necessary changes and/or improvements.
- Work with the Director, Clinical Research Operations to create and/or improve applicable Site Operations policies, SOPs and WIs.
- Participate in and provide direction for the design, writing and review of study documents including protocols, case report forms (CRFs), data management plans, monitoring plans, site budgets, statistical analysis plans, core lab documents, etc.
- Assist Business Development with benchmarking for budgets and development of Sponsor proposals and service agreements that include Site Operations.
- Function as an Executive Project Manager for assigned projects. Provide mentoring, support and back-up for all relevant project activities. Ensure overall quality and project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as ARO’s efficiency.
Here’s what you will need to bring to the table:
- BA/BS in a scientific field or equivalent experience.
- A minimum of 6 years of experience in clinical trials, including a minimum of 2 years clinical research project management experience.
- Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
- Experience with MS Office including Project PowerPoint, SharePoint, Word and Excel.
- Excellent interpersonal communication skills, organizational skills and a great attention to detail.
- Ability to organize, instruct and supervise staff, while promoting group effort and achievement.
- Ability to manage conflicts and resolve problems effectively.
- Ability and willingness to travel up to 15%.
Note: Viable applicants will be required to pass a background and education verification check.
At this time CPC is not able to provide relocation assistance to out-of-state candidates.
CPC is an academically led clinical research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 25 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/
• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan
• 10 paid holidays
• In-suite exercise room
• In-suite relaxation room
• In-office masseuse 3x/month
• Monthly fun events (i.e. sports games, potlucks, picnics)
• Flexible work schedules
Visit our web site to learn more about us and values we embrace: www.cpcmed.org.
An Equal Opportunity Employer
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, gender, gender identity, veteran status, marital status, sexual orientation, age 40 and over, disability, genetic information or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Dissabilities Act (ADA) and certain state or local laws. If you need assistance, please e-mail our Human Resources team.