Clinical Lead - US

About the Role

The Clinical Lead (CL) and Senior Clinical Lead provide direction and guidance to multi-country clinical teams in assigned project(s), coordinate site management and monitoring activities, and provide operational leadership to achieve on-time clinical deliverables on a project. They are accountable for developing the clinical monitoring plan, participant recruitment strategy, clinical team training and assurance of high-quality data on a clinical trial. They do this by ensuring high-quality site selection, review and approval of monitoring visit reports, review of data management plan, resolution of data queries and trending/analysis of protocol compliance.

Responsibilities

Clinical Lead responsibilities may include, but are not limited to;

• Manages the day-to-day clinical project team ensuring compliance of project deliverables and any mentoring required.
• Lead site identification and site selection activities.
• Prepare and attend Client Kick-Off Meetings (KOM) and present relevant clinical topics at investigator meetings.
• Drive the Clinical Management Plan (CMP) and annotated Monitoring Visit Report (MVR) development. Ensure CRAs have strong understanding of the CMP and are compliant with (MVR) timelines. Update CMP, as required.
• Ensure the clinical team is adequately trained on project-specific requirements.
• Ensure appropriate clinical input into relevant project specific plans, guidelines or materials (e.g. pharmacy manual, protocol deviation management plan, data 
management plan, eCRF guidelines, eTMF management plans, etc.).
• Develop and distribute Site Initiation Visit (SIV) materials based on materials provided from the Sponsor. Ensure CRA team’s understanding of clinical trial 
protocol and procedures prior to first SIV.
• Develop and distribute Source Data Verification tools and other relevant Monitoring tools and trackers for use by CRA prior to SIV.
• Lead the clinical team to ensure all study materials are in place before SIV.
• Drive the Development of project specific annotated report templates in accordance with any Sponsor requirements while ensuring CRAs have good 
understanding of project specific requirements prior to first visit type.
• Work with Project Manager (PM) and/or Regulatory Start-Up Manager (RSM) for Project to ensure Country Activation Forms and other relevant clinical 
documents across regions and coordinate initial shipment of both Investigational Product (IP) and non-IP supplies across regions inclusive of resupply.
• Develop and implement subject recruitment strategies at the study level. 
• Review MVRs in line with the annotated report within required timelines. Check for trends in action items, protocol deviations and ensure timely closure. Ensure
compliance by site and CRA with ICH-GCP and the CMP.
• Provide final approved documents to Sponsor as required and track report metrics in CTMS ensuring compliant metrics.
• Proactive identification of risks to clinical deliverables and development of risk management strategies within clinical scope. 
• Oversee safety reporting processes to ensure they are in line with regulatory requirements. 
• Commitment to ethical practices and maintaining high standards of professionalism and integrity.

Additional Responsibility for Senior Clinical Lead:
• Demonstrated ability to lead and manage a team effectively, including conflict resolution, decision-making, and motivating team members, especially on large 
global trials where more than one clinical lead is present along with a track record of delivering trials of high quality.
• Experience in mentoring and training more junior clinical lead staff, fostering a culture of continuous learning and professional development.
• Strategic thinking to drive studies proactively to deliver ahead of schedule
• Advanced knowledge and skills in specific therapeutic areas.
• Attend Bid Defense meetings and actively promote the clinical lead function.
• Act as a subject matter expert representing the clinical lead function for specific tasks such as Veeva super user, Risk Based Quality Management, etc.
• Actively contribute to process improvements and systems review, developing training and guidance documents to support the clinical lead function facilitating
knowledge sharing in global meetings.
• Identify out of scope tasks for entire clinical team and work with PM to ensure adequate budget coverage of out-of-scope tasks.
• Actively contribute to clinical team efficiency to ensure clinical team realisation stays within target of 85% on their projects by identifying areas of improvement 
and taking action to reduce unnecessary tasks.

Clinical Lead Qualifications & Experience:
• At least 5 years of experience as CRA (Clinical Research Associate)
• Must have performed advanced clinical monitoring tasks and site. management tasks at a Senior CRA level and demonstrated effective leadership, organization, communication, problem-solving and time management skills with solid understanding of risk management principles.
• Strong understanding of clinical quality, metrics compliance and the ability to meet deadlines in a fast and dynamic environment. 
• Experienced in coaching and mentoring clinical teams.
• Solid communication skills with fluency in both verbal and written English.
• Good understanding of GCP and applicable policies, confidently utilising available sources of information.
• Demonstrates an understanding of how to obtain local support to ensure compliance with local regulations. 
• Use of excellent analytical skills to generate and accurately understand data reporting using the relevant clinical trial management system(s).
• Must have an in-depth understanding of multi-country clinical trial regulations as well as site monitoring practices.
• Must have an in-depth understanding of various roles and responsibilities within projects to effectively coordinate communication and ensure timely delivery 
clinical milestones.
• Excellent problem-solving skills, with proven ability to identify/manage risks at 
both site and regional levels. 
Additional Requirements for Senior Clinical Lead
• At least 3 years’ experience as Clinical Lead (or equivalent role) with 5 years preferred at this level.
• Must have a proven record of leadership and successful study management in complex MRCT (Multi-Regional Clinical Trial) studies with high number of sites/subjects and large clinical team (CRA, IHCRA and clinical support roles).
• Strong leadership in cross-functional management and coordination of departments/vendors/clients to achieve clinical deliverables and solve issues.
• Experience in coaching and mentoring (Lead CRA, Clinical Lead, or equivalent).
• Experience with attending and supporting Bid Defence meetings.
• Good understanding of project financials inclusive of contracted scope, budgeted hours, and realization.

Education
• Graduate in a clinical or life-science related field
• Master’s degree or higher level preferred

Knowledge, Skills, and Abilities
• Relevant knowledge and skills in the global clinical trial environment.
• Experience and skills to manage large multi-centre clinical trials at the regional or global level. 
• Good level of internal and external customer–facing experience.
• Ability to build high performing and motivated clinical team - Self-motivated and detail-oriented.
• Ability to work confidently under pressure, manage crises effectively and maintain positive attitude despite adversity.

Salary Band - $135,000 – $160,000 Salary offered will be based on candidates experience level.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.  

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.