Dealer Network Strategist & Brand Standards Lead

Kaufmann; Pudahuel; Sur place; CLP 117 763 000 - 147 203 000; Plein temps

Résumé du poste

Kaufmann is seeking a Clinical Lead to oversee delivery of global clinical studies, ensuring milestones, budgets, and quality standards are met. The role collaborates with cross-functional teams and external partners to deliver trials efficiently from initiation to closeout.

The position requires leading clinical teams, managing recruitment, and applying regulatory knowledge to ensure compliant trial conduct across regions, including site visits and bid preparations.

Qualifications

• Bachelor's Degree in health care or life science.
• 5 years clinical research/monitoring experience or equivalent.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Understanding of project finances and budgeting.
• Strong written and verbal communication in English.

Responsabilités

• Ensure clinical delivery in compliance with regulatory requirements (GCP/ICH) and SOPs.
• Meet recruitment targets and implement recruitment strategies.
• Develop and manage risk mitigation plans for clinical projects.
• Ensure clinical quality and measurement of compliance across projects.
• Manage project finances, including Estimate at Completion (EAC).
• Identify clinical stakeholder landscape and manage internal/external communications.
• Lead clinical teams and provide guidance and trainings at project level.
• Mentor peers and contribute to clinical delivery strategy.
• Support bid defenses and participate in proposal development.
• Attend site visits as applicable to project delivery.

Connaissances

Clinical research

Project management

Regulatory knowledge

English communication

Leadership

Microsoft Office

Formation

Bachelor's degree in health care or life sciences

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

Durham, North Carolina, United States of America
Buenos Aires, Argentina
Santiago, Chile
Toronto, Ontario, Canada
São Paulo, Brazil
Full time
R
Job Overview
Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients' lives by bringing new drugs to the market faster. The Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times.
Essential Functions
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
- Accountable for meeting projects' recruitment targets and ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan and manage clinical risks through the project's lifecycle.
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
- Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
- Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
- Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
- Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
- Conduct regular team meetings and communicate appropriately to achieve objectives.
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
- May contribute to the development of the clinical delivery strategy for proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
- May mentor and coach new peers as they assimilate into this role.
- May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
- May attend site visits as applicable in support of project delivery.
Qualifications
- Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required Req
- Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience. Req
- Requires basic knowledge of Project management practices and terminology. Req
- Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.; Req
- Requires broad protocol knowledge and therapeutic knowledge.; Req
- Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates. Req
- Requires understanding of project finances. Req
- Knowledge of clinical trials - Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
- Communication - Strong written and verbal communication skills including good command of English language.
- Problem solving - Problem solving skills.
- Organization - Planning, time management and prioritization skills.
- Prioritization - Ability to handle conflicting priorities.
- Quality - Attention to detail and accuracy in work. Results-oriented approach to work delivery and output.
- Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
- IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
- Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Cross-collaboration - Ability