Clinical Lead

Novotech Global•South San Francisco, CA

9d•$135,000 - $170,000

About The Position

The Clinical Lead (CL) and Senior Clinical Lead provide direction and guidance to multi-country clinical teams on assigned projects, coordinate site management and monitoring activities, and provide operational leadership to deliver clinical milestones on time. They are accountable for developing the clinical monitoring plan and participant recruitment strategy, training clinical teams, and assuring high-quality trial data. This includes ensuring high-quality site selection, reviewing and approving monitoring visit reports, reviewing data management plans, resolving data queries, and trending and analyzing protocol compliance. The role manages day-to-day clinical project activities and works with project and regulatory start-up colleagues, sponsors, sites, and cross-functional teams. It supports study start-up, site initiation, monitoring, safety reporting, risk management, and clinical documentation while ensuring compliance with ICH-GCP, applicable regulations, and project requirements. The Senior Clinical Lead additionally provides strategic leadership on complex global trials, mentors clinical lead staff, contributes to process and systems improvements, supports bid defenses, and helps manage scope, budgets, and team efficiency. Novotech is a global full-service clinical Contract Research Organization with a network of more than 30 offices across Asia-Pacific, the United States, and Europe. The company describes a collaborative, inclusive workplace and offers flexibility, development opportunities, and support for work-life balance.

Requirements

At least 5 years of experience as a Clinical Research Associate (CRA).
Advanced clinical monitoring and site management experience at Senior CRA level.
Demonstrated leadership, organization, communication, problem-solving, and time-management skills, with a solid understanding of risk management principles.
Strong understanding of clinical quality and metrics compliance, and ability to meet deadlines in a fast-paced, dynamic environment.
Experience coaching and mentoring clinical teams.
Fluency in spoken and written English and strong communication skills.
Good understanding of GCP and applicable policies, and confidence using available information sources.
Understanding of how to obtain local support to ensure compliance with local regulations.
Excellent analytical skills, including generating and accurately interpreting data reports using relevant clinical trial management systems.
In-depth understanding of multi-country clinical trial regulations and site monitoring practices.
In-depth understanding of project roles and responsibilities to coordinate communication and deliver clinical milestones on time.
Excellent problem-solving skills and demonstrated ability to identify and manage risks at site and regional levels.
Graduate qualification in a clinical or life-science-related field.
Knowledge and skills relevant to the global clinical trial environment.
Experience and skills managing large multi-centre clinical trials at regional or global level.
Experience in internal and external customer-facing roles.
Ability to build high-performing and motivated clinical teams; self-motivated and detail-oriented.
Ability to work confidently under pressure, manage crises effectively, and maintain a positive attitude.
For Senior Clinical Leads: at least 3 years of experience as a Clinical Lead or in an equivalent role.
For Senior Clinical Leads: proven leadership and successful study management in complex multi-regional clinical trials with many sites and subjects and large clinical teams.
For Senior Clinical Leads: strong cross-functional leadership and coordination of departments, vendors, and clients to achieve clinical deliverables and resolve issues.
For Senior Clinical Leads: experience coaching and mentoring Lead CRAs, Clinical Leads, or equivalent roles.
For Senior Clinical Leads: experience attending and supporting bid defense meetings.
For Senior Clinical Leads: understanding of project financials, including contracted scope, budgeted hours, and realization.

Nice To Haves

Master’s degree or higher.
For Senior Clinical Leads: 5 years of experience as a Clinical Lead or in an equivalent role is preferred.

Responsibilities

Manage the day-to-day clinical project team, ensuring compliance with project deliverables and providing mentoring as needed.
Lead site identification and site selection activities.
Prepare for and attend Client Kick-Off Meetings and present relevant clinical topics at investigator meetings.
Drive development of the Clinical Management Plan (CMP) and annotated Monitoring Visit Report (MVR); ensure CRAs understand and follow the CMP and meet MVR timelines, and update the CMP as required.
Ensure the clinical team is trained on project-specific requirements.
Provide clinical input to project-specific plans, guidelines, and materials, including pharmacy manuals, protocol deviation management plans, data management plans, eCRF guidelines, and eTMF management plans.
Develop and distribute Site Initiation Visit materials based on sponsor-provided materials, and ensure the CRA team understands the protocol and procedures before the first SIV.
Develop and distribute Source Data Verification tools, monitoring tools, and trackers for CRA use before SIV.
Lead the clinical team in ensuring all study materials are in place before SIV.
Drive development of project-specific annotated report templates in accordance with sponsor requirements and ensure CRAs understand requirements before each first visit type.
Work with the Project Manager and/or Regulatory Start-Up Manager to ensure Country Activation Forms and other relevant clinical documents are available across regions, and coordinate initial and resupply shipments of investigational product and non-IP supplies.
Develop and implement study-level subject recruitment strategies.
Review MVRs against annotated reports within required timelines; monitor action items and protocol deviations, ensure timely closure, and ensure site and CRA compliance with ICH-GCP and the CMP.
Provide final approved documents to the Sponsor as required and track compliant report metrics in CTMS.
Proactively identify risks to clinical deliverables and develop risk-management strategies within clinical scope.
Oversee safety reporting processes to ensure compliance with regulatory requirements.
Maintain ethical practices and high standards of professionalism and integrity.
For Senior Clinical Leads: lead and manage teams, resolve conflicts, make decisions, motivate team members, and deliver high-quality trials, including large global trials.
For Senior Clinical Leads: mentor and train more junior clinical lead staff and foster continuous learning and professional development.
For Senior Clinical Leads: use strategic thinking to drive studies proactively and deliver ahead of schedule.
For Senior Clinical Leads: attend bid defense meetings and promote the clinical lead function.
For Senior Clinical Leads: act as a subject matter expert for assigned tasks, such as Veeva super-user activities or Risk Based Quality Management.
For Senior Clinical Leads: contribute to process improvements and systems reviews, develop training and guidance documents, and facilitate knowledge sharing in global meetings.
For Senior Clinical Leads: identify out-of-scope work for the clinical team and work with the Project Manager to ensure adequate budget coverage.
For Senior Clinical Leads: improve clinical team efficiency and maintain project realization within the stated 85% target by identifying and reducing unnecessary tasks.