***Diabetes experience required

***Must be willing to work out of San Francisco office 3 days/week

The Senior Clinical Operations Leader is responsible for overseeing the functional team members and their activities across all geographies, liaising with the sponsor, project leadership, site management and all other related internal and external stake holders to ensure that the Clinical Operations deliverables are met on time, within budget, and with quality. The Senior Clinical Operations Leader has overall accountability for the execution of the clinical operations strategy and plan within the project and can competently and independently lead the clinical team.  The Senior Clinical Operations Leader may act in either a blinded/masked or unblinded/unmasked capacity based on business needs.  The Senior Clinical Operations Leader must be willing and able to function as a Global Clinical Operations Leader independently when needed. 

May act as Project Leader (Standalone Functional Leader) for projects involving limited scope of services, where no Project Leader is assigned. 

This position is responsible for the global coordination of the clinical team on any size project(s) and therefore acts as a role model and/or coach for the team. 

Additional responsibilities may include Clinical Operations Leader mentorship, participation in Clinical Operations Leader training and support, fulfilling subject matter expert roles within Clinical Operations, supporting business development opportunities, and involvement in departmental workstreams when appropriate.

Key Accountabilities:

Sponsor Liaison

• Effectively communicate with internal and external customers as well as third party vendors.
• Build trusted partnerships with sponsor and other functional leaders
• Develop and recommend strategic solutions to internal team and sponsors to increase efficiencies and reduce costs, timelines, etc.
• Prioritize effectively and respond to urgent requests within team or from sponsor.
• Seek out opportunities to leverage relationships with clients for future sales

Project Initiation

• Oversee and/ or manage study start-up activities
• Provide inputs to project tools and study plans
• Provide input to the format and content for sponsor reports/templates, if applicable 
• Provide input to and oversight of site selection strategy plan
• Develop site selection and monitoring plans
• Review and provide input into patient recruitment and retention plan templates
• Ensure all team members have access to study systems, tools and documents
• Establish efficient / effective working relationships with other Functional Leaders and colleagues across geographies within a given study/program
• Develop study plans, tools, forms and templates pertaining to Clinical Operations
• Provide input on relevant vendor plans, clinical supply strategy and management. Support vendor access and assist with troubleshooting vendor issues.

Project Execution

• 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 the use of resources over life cycle of project and/or program
• Provide study productivity targets to project team members
• Provide performance feedback on team members and work with line management, as appropriate
• To effectively recognize potential problem areas early and develop robust contingency and risk management plans,
• Own and drive study timelines, patient recruitment and retention, and data cleaning to ensure successful outcome of the project and/or program 
• Proactively plan and manage large/complex or multiple projects within a program (ability to prioritize multiple timelines and deliverables simultaneously)
• Liaise with vendors to support clinical activities
• Oversee maintenance and quality check of TMF
• Maintain and ensure quality of work generated and escalate and follow up, as appropriate
• Ensure appropriate handover between clinical project team members with support from Clinical Operations Managers
• Implement and proactively initiate process improvements within the project and/or program, as and when 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 actively seeks ways to optimize resources, ensuring efficiency and cost-effectiveness in clinical operations team
• In exceptional circumstances, may be required to conduct site visits as per sponsor or project demands
• Participate in or lead sponsor, investigator, and team meetings
• Prepare, participate in, and follow up on audits / inspections
• Participate and deliver all required applicable trainings, as appropriate

Project Close-out

• Collaborate with project team (e.g. Project Leader and Data Management Lead) 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 all clinical administrative closeout procedures are completed according to the close-out process
• Together with Project Leader, ensure project is archived and all 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 Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedures
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims)
• Responsible for reviewing site qualification, initiation, monitoring, and close-out visit reports to ensure they meet quality standards, Standard Operating Procedures (SOPs), ICH-GCP guidelines, and protocol specifications.
• Documentation of findings and follow-up actions, identifying potential data quality or compliance issues, assessing their impact on study timelines, and escalating critical concerns with recommended solutions.

Skills:

The Senior Clinical Operations Leader is expected to demonstrate a higher level of competency in the following skills when compared to the Clinical Operations Leader.

Leadership skills that include:

• Ability to provide mentorship to Clinical Operations Leaders and other clinical staff
• Ability to lead, motivate and drive  virtual teams across locations and cultures and to foster individual ownership and commitment of the team to success
• Ability to foster positive team morale while managing changes in the project to minimize adverse impacts
• Ability to carefully weigh the priority of project tasks and direct team accordingly
• Ability to 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
• Adept in risk management, able to proactively evaluate and mitigate and/or address risks
• Ability to prioritize multiple timelines and deliverables simultaneously
• Ability to conduct root cause analysis in business problem solving and develop and implement process improvement
• Robust financial acumen and ability to prevent and/or address clinical overconsumption
• Ability to function as Subject Matter Expert within Clinical Operations
• Strong customer focus and ability to interact professionally within a sponsor organization
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Effective time management in order to meet all metrics, internal/external deliverables, and study/program objectives
• Ability to clearly define for the clinical team: project roles, milestones, metrics, and the ability to create, track, report, and monitor individual and project level metrics

Personal skills that include:

• Ability to take initiative and work independently
• Ability to successfully work in a team environment
• Sense of urgency in driving study deliverables to ensure timely completion of study tasks
• Resilient in daily management and when faced with unexpected requests or obstacles
• Commitment to high quality work and respective consistent performance
• Excellent interpersonal, oral, and written communication skills
• Ability to gain trust and confidence with a sponsor as well as within Parexel
• Good learning ability
• Strong critical thinking skills
• Action-oriented
• Excellent presentation skills
• Good consulting skills
• A flexible attitude with respect to assignments and new learning
• Engaged and accountable for timely identification, mitigation, and management of all risks
• Adept in supporting sponsor decision making through risk analysis and reviewing possible options to meet the same goal
• Ability to travel as required

Business / operational skills that include

• Customer focus
• Commitment to delivery and first-time quality
• Proactive issue identification and resolution
• Demonstrates strategic planning and foresight with proactive control of study
• Provision of win-win solutions to problems
• In-depth understanding and experience in the clinical trial process and very good 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, Teams, Webex, MS Teams and other collaboration platforms.

Knowledge and Experience: 

• Strong command of written and spoken English language, local language proficiency as required
• Proven clinical experience or management experience in healthcare, clinical research, or contract research organization
• Substantial 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 research
• Substantial experience in Coordination of Clinical Trials – preferably as Clinical Operations Leader or proven experience in a similar role
• Strong understanding of cross-functional activities

Education:

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

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