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Associate Clinical Site Manager (trainee)

Wavre, Wallonia, Belgium Date posted 03/12/2019 Job ID 51573BR

At Parexel, we believe that the power to work independently and intelligently should be yours every day. Your ability to understand our clients’ needs and achieve quality results is critical to our reputation as one of the best clinical research organizations (CROs) in the world.

As a Clinical Site Manager (CRA) within Parexel's Global Monitoring Operations Group, we support you with leading-edge technology, the highest caliber team members, and managers who know your strengths. If you're looking for flexibility and work-life balance, we're here to listen and help you move forward with your individual career path.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Innovative
  • Problem-Solver
  • Communicator
  • Tech-Savvy
  • Confident
  • Independent

"One thing I enjoy about my job is when I see patients feel better with the new treatments; that is very gratifying. I always think about the pleasure our work can give patients and their loved ones."

- Wagner – Associate Manager, Clinical Operations
 

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Compensation

    Competitive salaries and bonus structure based on individual metrics.

Responsibilities

The Role for Associate Clinical Site Manager (ACSM) has been created in PAREXEL to train and develop people, without any experience in clinical research. During the training period (minimum 6 months), ACSM is responsible for learning and developing skills and competencies to work in a clinical research environment. At the end of this period the ACSM would be ready to work independently within Global Clinical Operations Department in PAREXEL.

Key Accountabilities:

• Complete all mandatory trainings in LMS
• Do all pre-work that applies to each training activity
• Complete and deliver on time all activities including post-training activities
• Attend all on-going, relevant trainings, including Continuing Education Workshops (CEW) that are applicable
• Attend all training activities organized for this role (in the country orat international level)
• Learn to work in compliance with ICH-GCP Guidelines, applicable international and local regulations, PAREXEL SOPs, other PAREXEL and study specific procedures and requirements
• Arrange on-site observational visits and logistics (e.g. travel arrangements).
• Perform on-site observational visits (Qualification, Initiation, Monitoring and Termination) with appropriate support; apply judgment and knowledge to independently resolve site issues,
Work with the mentor in the visit report and follow up letters writing activities.
• Successfully pass all assessments related to this role
• Complete routine departmental administrative tasks in a timely manner (e.g. times, metrics, concur etc.)
• Attend to all internal activities and corporate meetings.
• Perform project specific training agreed to understand the main project activities
• Ensure the basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and induction period, shadow efficient delivery working in two or three.
• Help the local team in completing Clinical Trial Management defined trial
Systems (CTMS) and study specific trackers
• Track, scan, code and apply naming convention and send documents to the relevant study e-CF Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan, if applicable
• Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP) if applicable
• Assist with the creation and completion of the Investigator Site File if applicable
• Support in on-site / remote visits preparation and follow-up if applicable

Qualifications

Skills:

• Ability to interact professionally within a client organization with the support of manager or team members
• Flexible and positive attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm
• Attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
• Sound interpersonal, verbal, and written communication skills
• Sound proactive and problem-solving skills
• Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables
• Effective time management to meet daily metrics, team objectives, and department goals
• Shows commitment to and performs consistently high-quality work
• Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned
• Willing and able to travel locally and internationally occasionally as required.
• Holds a driver’s license where required.

Knowledge and Experience:
• Previous relevant work experience valuable
• Proficient in written and oral English and fluent in relevant local language

Education:
• Educated to degree level (biological science, pharmacy or other health-related discipline preferred) or equivalent nursing qualification

Please note – in order to be considered, you must be able to speak English, French and Dutch fluently. This is a full-time office-based program both focused on CSM and ICSM for a 5 month duration.

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