Senior Clinical Trial Manager - San Francisco - Diabetes Experience Required

Parexel

6d•Hybrid

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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.

Requirements

Diabetes experience required
Must be willing to work out of San Francisco office 3 days/week
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.
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
Degree in a life science, nursing qualification or relevant clinical and or clinical management experience

Responsibilities

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
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.
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
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
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.