Clinical Lead

Novotech; Durham (NC); Hybrid; USD 135,000 - 160,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Wellness programs

Ongoing development programs

Inclusive work environment

Job summary

Novotech is seeking a Clinical Lead to steer multi-country clinical teams, coordinate site management and monitoring activities, and ensure high-quality data and on-time deliverables across assigned projects.

You will lead the clinical monitoring plan, recruitment strategy, training, risk management, and involvement in Bid Defense meetings, with a track record of team leadership in MRCTs and solid GCP knowledge.

Qualifications

• Graduate in a clinical or life-science field.
• 5+ years as CRA with senior monitoring and site management duties.
• Proven leadership and mentoring of clinical teams.
• Strong English communication and GCP knowledge.

Responsibilities

• Manage daily clinical project team performance and mentoring.
• Develop training materials for project-specific needs.
• Provide clinical input into plans and guidelines (CMP, MVR, etc.).
• Coordinate shipment of IP and non-IP supplies across regions.
• Develop and implement study-wide recruitment strategies.
• Review MVRs and data trend analyses to ensure quality and compliance.
• Identify risks and implement risk management strategies.
• Oversee safety reporting and regulatory compliance.
• Lead cross-functional teams and contribute to process improvements.

Skills

Leadership

Mentoring

Strategic thinking

English fluency

Project coordination

Problem-solving

Time management

Communication

Education

Graduate in clinical or life-science field

Master's degree or higher preferred

Job description

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. 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. Ensure high-quality site selection, review of monitoring visit reports, review of data management plan, oversight and management of data queries and trending/analysis across designated projects.

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 for all stages of a study.
• Develop training materials for clinical teams ensuring they are adequately trained on project-specific requirements/plans.
• 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, Clinical Management Plan (CMP) and annotated Monitoring Visit Report (MVR), etc.).
• 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, trends analyses of action items, protocol deviations. Ensure compliance by site and CRA with ICH-GCP and the CMP.
• Proactive identification of risks 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, conflict resolution, decision-making, motivating team members, especially on large global trials
• Experience in mentoring and training.
• Strategic thinking , with 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
• Actively contribute to process improvements.
• Identify out of scope tasks to ensure adequate budget coverage.
• Actively contribute to clinical team efficiency
• 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.
• 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.
• Excellent analytical skills, understand data reporting using the relevant system(s).
• In-depth understanding of multi-country clinical trial regulations as well as site monitoring practices.
• In-depth understanding of roles and responsibilities within projects to effectively 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.
• 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, coordination and solving of 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
• 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.