Associate Manager, Clinical Operations (CRA)

This position will be managing CRA's.

The Manager is responsible for the oversight of a team or group. This includes ensuring successful performance and delivery of his/her direct report’s project deliverables, on time with high quality. The Manager is responsible to resource client projects with suitably developed professionals and to retain and develop these professionals within PAREXEL. The Manager may also be part of a project team and be responsible for successful delivery of his/her own project deliverables, on time with high quality. The Manager is responsible to promote new business by participating in project bids and client presentations

as appropriate. The Manager is responsible to provide clinical consultation to project teams as needed.

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

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.

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