PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Clinical Operations Leader
Job Description:
The Clinical Operations Leader is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Global Research Operations deliverables (timeline, quality, productivity) are met. The Clinical Operations Leader has overall accountability for the execution of the clinical operations strategy on the project. May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned. Tasks assigned as responsibility include all aspects of the GRO discipline.
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 activities, in small size studies
-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
-Develop site selection and monitoring plans for the team
-Review and provide input into patient recruitment plan and retention plan
-Ensure 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
-Develop study plans, tools and forms.
Project Implementation, Control & Evaluation
-Provide leadership and direction to project team members
-Identify, organize and deliver (where appropriate) study specific training in collaboration with
Project Leader and Project Specialists
-Evaluate and identify resourcing needs and continuously monitor over life 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
-Early recognize 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
-Oversee 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
-Implement 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 visits as per client or project demands
-Participate in client, investigator and team meetings
-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 Project Leader ensure all administrative closeout procedures are completed,
according to Project Close-out Checklist
-Together with Project Leader ensure project is archived and all documentation returned to the client as specified by the contract
-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
-excellent presentation skills
-good consulting skills
-flexibility to change
-ability to travel as required
-Business / operational skills that include
-customer focus
-commitment to delivery and quality
-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
Candidate Profile:
Minimum Work Experience
-Substantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials.
-Experience in Coordination of Clinical Trials, Preferably relevant working experience as an Associate Clinical Operations Leader or proven experience in a similar role
-Individuals should have a strong understanding of the cross functional activities
Education
-Degree in a life science, nursing qualification or relevant experience
Language Skills
-Competent in written and oral English
Note: Candidate with Relevant Clinical Trial Lead / Project Management in Clinical Research of atleast 1+ years preferably Global Clinical Trials exposure can directly share their CV to Kirloskar.das@parexel.com
Additional Information:
Experience: 1-2 years
Location: Bengaluru/Bangalore
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
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