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Associate Clinical Operations Leader

1 month ago


Mumbai, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

Client Liaison

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.

Project Initiation & Planning

Manage study start-up activities Provide input to project tools, PM 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 all team members have access to tools and documents Establish efficient / effective working relationships with other functional Leaders and coordinators Support develop study plans, tools and forms.

Project Implementation, Control & Evaluation

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 Support evaluating and identifying resourcing needs and continuously monitor the use of resources over project life cycle 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 with support from Clinical Operations Managers Support implementing and instigating process improvements Provide input to the Revenue Recognition forecast Identify changes in scope and liaise with Clinical Operation Leader and/or Project Leader May be required to conduct site visits as per client or project demands Participate in client, investigator and team meetings as appropriate Prepare, participate in and follow up on audits / inspections Participate in all required applicable trainings

Project Close-out

Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activities Together with Clinical Operations Leader and Project Leader ensure all administrative closeout procedures are completed according to Project Close-out Checklist Together Clinical Operations Leader and with Project 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

Operational

Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedure Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims)

Skills:

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 A flexible attitude with respect to assignments and new learning Ability to travel as required

Business / operational skills that include

Customer focus Commitment to quality work and respective consistent performance Proactive issue identification and resolution In-depth understanding and experience in the clinical trial process and understanding of all aspects of project life cycle Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations Ability to become proficient with Parexel systems Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Power Point, Outlook, WebEx

Knowledge and Experience:

Strong command of written and spoken English language, local language proficiency as required Relevant work experience - CRA 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 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

Education:

Degree in a life science, nursing qualification or relevant clinical and or clinical management experience