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Manager, Clinical Operations - Remote

Anywhere, NY, USA | Parexel

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    Operations / Production
  • Experience:
Job Description:
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Job Description



  • Effectively communicate with internal and external customers as well as third party vendors

  • Prioritize effectively and respond to urgent requests within team or from sponsor.

  • Manage study start-up activities

  • Provide input to project tools, PL project plan, Central File Maintenance Plan

  • Provide input to the format and content for sponsor reports

  • Provide input to and oversight of site selection strategy plan

  • Support development of site selection and monitoring plans for the team

  • Review and provide input into patient recruitment plan and retention plan

  • Assist with ensuring that all team members have access to tools and documents

  • Establish efficient / effective working relationships with other functional Leaders and coordinators across geographies and projects within a given program

  • Support development of all study plans, tools and forms.

  • Provide leadership and direction to project team members

  • Provide input to identifying, organizing and delivering (where appropriate) study specific training in collaboration with Project Leader and Project Specialists. If Clinical Manager has concerns about CRA’s/CMA’s/CTS’ intelligibility, CM may ask relevant project team member to train such CRAs/CMAs/CTSs.

  • Evaluate and identify resourcing needs and continuously monitor overlife cycle of project

  • Provide productivity targets to project team members

  • Provide performance feedback on team members as appropriate

  • Address identified and escalated site issues and drive to closure

  • Support early recognition of areas of potential problems and provide input to contingency plans

  • Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project

  • Support overseeing maintenance and quality check of Central Files

  • Maintain and assure quality of work generated and escalate and follow up as appropriate

  • Ensure appropriate handover between project team members

  • Support implementing and instigate process improvements within the project

  • Provide input to the Revenue Recognition forecast

  • Identify changes in scope and liaise with Project Leader

  • May be required to conduct site/remote visits or site contacts as per client or project demands in case that assigned CRA is not appropriate person or not available.

  • Participate in client, investigator and team meetings

  • Prepare, participate in and follow up on audits / inspections

  • Participate in all required applicable trainings 

  • Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activities

  • Together with Project Leader ensure all administrative closeout procedures are completed, according to Project Close-out Checklist

  • Together withProject Leader ensure project is archived and all documentation returned to the client as specified by the contract

  • May participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions


Qualifications


Leadership skills that include:



  • ability to lead a virtual team across locations and cultures

  • carefully weigh the priority of project tasks and direct team accordingly

  • enlist the support of team members in meeting goals

  • ability to negotiate and influence with diplomacy in order to achieve results

  • ability to make decisions even in ambiguous situations to achieve project timelines and quality

  • ability to proactively identify and solve problems by using a logical, systematic approach

  • ability to conduct root cause analysis in business problem solving and process improvement development

  • strong customer focus, ability to interact professionally within a client organization

  • ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail

  • effective time management in order to meet daily metrics or team objectives


Personal skills that include:



  • ability to take initiative and work independently

  • ability to successfully work in a team environment

  • sense of urgency in completing assigned tasks

  • commitment to high quality work and respective consistent performance

  • excellent interpersonal, oral and written communication skills

  • ability to gain trust and confidence with a client as well as within PAREXEL

  • good learning ability

  • action oriented

  • good presentation skills

  • good consulting skills

  • flexibility to change

  • ability to travel as required


Business / operational skills that include:



  • customer focus

  • commitment to high quality work and respective consistent performance

  • proactive issue identification and resolution

  • provision of win-win solutions to problems

  • in-depth understanding and experience in the clinical trial process

  • knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations

  • proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Outlook and Windows.


People management skills that include:



  • Demonstrated ability to successfully manage a full workload across multiple-projects.

  • Ability to manage and motivate direct reports

  • Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions)

  • A flexible attitude with respect to work assignments and new learning

  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

  • Ability to work in a matrix environment and to value the importance of teamwork.

  • Excellent negotiation skills


Language Skills:



  • Competent in written and oral English and local language


Relevant work experience :



  • CRA/CMA experience or minimum substantial relevant experience (preferably on site monitoring experience)

  • “Coordinating experience”: Preferably obtained while working in a Sr. CRA or Sr. CMA position

  • Demonstrated ability to manage and motivate direct reports is required

  • Substantial experience in clinical research in Clinical functions. Individuals should have potential to understand cross functional activities related to data processing, cleaning and site management

  • Individuals should have a strong understanding of the cross functional activities 

  • Degree level (biological science, pharmacy or other health related discipline preferred) or relevant clinical or business equivalent.


Why Work at Parexel


There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?


That’s Parexel. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.


EEO Disclaimer


Parexel is an equal opportunity employer.Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


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