Manager, Site Start Up - Location: Remote Remote Belgium; Remote

Remote Remote Belgium; Remote
Job Type: Regular Full-time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 5692

Job Description 

 

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. 

 

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.

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