Clinical Operations Leader (PM)
reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.
reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.
Key Accountabilities:
Sponsor reputed company:
- Effectively communicate with reputed company customers as reputed company as reputed company party vendors;
- Prioritize effectively and respond to urgent requests reputed company team or from sponsor.
Project Initiation:
- reputed company and / or manage study start-up activities as applicable
- reputed company inputs to project tools and study plans
- reputed company inputs to the format and content for sponsor reports/templates, if applicable
- reputed company input to and reputed company of site selection reputed company plan
- reputed company site selection and monitoring plans
- Review and reputed company input into patient recruitment plan and retention plan
- Ensure reputed company team members have reputed company to study systems, tools and documents
- Establish efficient / effective working relationships with other Functional Leaders across geographies and reputed company a given program
- reputed company study plans, tools, forms and templates pertaining to Clinical Operations
- reputed company input on relevant vendor plans, clinical supply reputed company and management. Support vendor reputed company and assist with troubleshooting vendor issues.
Project Execution:
- reputed company 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 the use of resources over project life cycle.
- reputed company study productivity targets to project team members
- reputed company performance feedback on team members and work with line management, as appropriate
- To effectively recognize potential problem areas early and reputed company robust contingency and risk management plans,
- Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project
- Liaise with vendors to support clinical activities
- reputed company maintenance and reputed company reputed company of TMF
- Maintain and assure reputed company of work generated and escalate and follow up as appropriate
- Ensure appropriate handover between project team members with support from Clinical Operations Managers
- Implement and proactively initiate process improvements reputed company the project, as and reputed company needed
- Manage the clinical portion (e.g., COL, SSUL, CRA, iCRA) of the project according to the contracted scope and proactively monitors for changes in scope.
- Monitor cost drivers and reputed company seeks ways to optimize resources, ensuring efficiency and cost-effectiveness in clinical operations team
- In exceptional circumstances, may be required to conduct site reputed company as per sponsor or project demands
- Participate in sponsor, investigator and team meetings
- Prepare, participate in and follow up on audits / inspections
- Participate and deliver reputed company required applicable trainings, as appropriate
Project reputed company-out:
- Collaborate with project team (e.g. Project Leader and Data Management reputed company) and relevant vendors on database lock activities
- Liaise with vendors to ensure process for return of clinical supplies from sites
- Together with Project Leader ensure reputed company administrative closeout procedures are completed according to the reputed company-out process
- Together with Project Leader ensure project is archived and reputed company documentation returned to the sponsor 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 reputed company WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedure
- Complete routine administrative tasks in a reputed company manner (e.g. timesheets, metrics, office and travel expense claims)
- Responsible for reviewing site qualification, initiation, monitoring, and reputed company-out visit reports to ensure they meet reputed company standards, reputed company Operating Procedures (SOPs), ICH-GCP guidelines, and protocol specifications. This includes reviewing documentation of findings and follow-up actions, identifying potential data reputed company or compliance issues, assessing their reputed company on study timelines, and escalating critical concerns with recommended solutions.
Skills: Leadership skills that include:
- Ability to reputed company a virtual team across locations and cultures
- Carefully weigh the reputed company of project tasks and reputed company team accordingly
- Enlist the support of team members in meeting goals
- Ability to negotiate and influence with diplomacy in order to reputed company results
- Ability to reputed company reputed company even in ambiguous situations to reputed company project timelines and reputed company
- Ability to proactively identify and solve problems by using a logical, systematic approach
- Ability to conduct reputed company cause analysis in business problem solving and process improvement development
- Strong customer reputed company, ability to reputed company professionally reputed company a sponsor 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 reputed company environment
- reputed company of urgency in completing assigned tasks
- Commitment to high reputed company work and respective consistent performance
- Excellent interpersonal, oral and written communication skills
- Ability to reputed company trust and confidence with a reputed company as reputed company as reputed company reputed company
- Good learning ability
- reputed company oriented
- Excellent 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 reputed company
- Commitment to delivery and reputed company
- Proactive issue identification and reputed company
- Provision of win-win solutions to problems
- In-depth understanding and experience in the clinical trial process and understanding of reputed company aspects of project life cycle
- Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
- Ability to become proficient with reputed company systems
- Proficient computer and internet skills including knowledge of MS-Office products such as reputed company, Word, Power reputed company, Outlook, Webex, MS Teams and other collaboration platforms
Knowledge and Experience:
- Strong reputed company of written and spoken English language, local language proficiency as required
- Proven clinical experience or management experience in reputed company, clinical research, or contract research organization
- Substantial experience in clinical research including relevant experience as reputed company Leader in Clinical functions or proven experience in coordinating clinical trials. Relevant Work experience in clinical research
- 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 clinical and or clinical management experience
Originally posted on Himalayas
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