Clinical Operations Leader

1 month ago

Bengaluru, India Parexel Full time

Key Accountabilities:

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 activitiesProvide input to project tools, PM plan, Central File Maintenance PlanProvide input to the format and content for sponsor reportsProvide input to and oversight of site selection strategy planDevelop site selection and monitoring plans for the teamReview and provide input into patient recruitment plan and retention planEnsure all team members have access to tools and documentsEstablish efficient / effective working relationships with other functional Leaders and coordinators across geographies within a given programDevelop study plans, tools and forms.

Project Implementation, Control & Evaluation:

Provide leadership and direction to project team membersIdentify, organize and deliver (where appropriate) study specific training in collaboration with Project Leader and Project SpecialistsEvaluate and identify resourcing needs and continuously monitor the use of resources over project life cycleProvide productivity targets to project team membersProvide performance feedback on team members as appropriateAddress identified and escalated site issues and drive to closureEarly recognize areas of potential problems and provide input to contingency plansMonitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the projectOversee maintenance and quality check of Central FilesMaintain and assure quality of work generated and escalate and follow up as appropriateEnsure appropriate handover between project team members with support from Clinical Operations ManagersImplement and instigate process improvements within the projectProvide input to the Revenue Recognition forecastIdentify changes in scope and liaise with Project LeaderMay be required to conduct site visits as per client or project demandsParticipate in client, investigator and team meetingsPrepare, participate in and follow up on audits / inspectionsParticipate in all required applicable trainings

Project Close-out:

Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activitiesTogether with Project Leader ensure all administrative closeout procedures are completed according to Project Close-out ChecklistTogether with Project Leader ensure project is archived and all documentation returned to the client as specified by the contractParticipate 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 procedureComplete 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 culturesCarefully weigh the priority of project tasks and direct team accordinglyEnlist the support of team members in meeting goalsAbility to negotiate and influence with diplomacy in order to achieve resultsAbility to make decisions even in ambiguous situations to achieve project timelines and qualityAbility to proactively identify and solve problems by using a logical, systematic approachAbility to conduct root cause analysis in business problem solving and process improvement developmentStrong customer focus, ability to interact professionally within a client organizationAbility to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detailEffective time management in order to meet daily metrics or team objectives

Personal skills that include:

Ability to take initiative and work independentlyAbility to successfully work in a team environmentSense of urgency in completing assigned tasksCommitment to high quality work and respective consistent performanceExcellent interpersonal, oral and written communication skillsAbility to gain trust and confidence with a client as well as within PAREXELGood learning abilityAction orientedExcellent presentation skillsGood consulting skillsA flexible attitude with respect to assignments and new learningAbility to travel as required

Business / operational skills that include:

Customer focusCommitment to delivery and qualityProactive issue identification and resolutionProvision of win-win solutions to problemsIn-depth understanding and experience in the clinical trial process and understanding of all aspects of project life cycleKnowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulationsAbility to become proficient with PAREXEL systemsProficient 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 requiredProven clinical experience or management experience in healthcare, clinical research, or contract research organizationSubstantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials. Relevant Work experience in clinical researchExperience in Coordination of Clinical Trials – Preferably relevant working experience as an Associate Clinical Operations Leader or proven experience in a similar roleIndividuals 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

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