Clinical Manager at Adalvo – Lead Clinical Research Projects, Apply Now!
Are you ready to advance your clinical research career? Adalvo is seeking a passionate and experienced Clinical Manager to join our fast-paced, dynamic team. In this role, you will oversee the planning, management, and execution of clinical trials, contribute to regulatory strategies, and collaborate with cross-functional teams to deliver excellence. If you’re driven, detail-oriented, and eager to make a global impact, Adalvo is the place for you!
About Company:
Welcome to Adalvo, a leading healthcare organization dedicated to providing top-quality care and innovative solutions to improve the well-being of our patients. We are a team of passionate professionals committed to making a positive impact in the healthcare industry.
Job Title: Clinical Manager
We are currently seeking a dedicated Clinical Manager to join our team at Adalvo. The ideal candidate will have strong leadership skills, clinical expertise, and a passion for delivering exceptional patient care.
Responsibilities
Clinical Strategy & Product Development
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Provide expert clinical input during product selection and pipeline development, including for complex generics and 505(b)(2) applications.
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Develop clinical strategies and feasibility plans for new and differentiated products.
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Propose innovative approaches and clinical waiver strategies for regulatory efficiency as Clinical Manager.
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Contribute to the ideation and evaluation of new products alongside Business, R&D, and Portfolio teams.
Regulatory & Scientific Documentation
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Prepare and review clinical synopses, protocols, and scientific advice documentation.
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Provide clinical inputs for briefing books and controlled correspondence to health authorities (US-FDA, EMA, APAC).
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Assist in drafting responses to regulatory queries and provide clinical support for IP litigations.
Study Oversight & Vendor Management
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Manage the full lifecycle of assigned studies (BA/BE, PK, Phase III, patient-based trials), ensuring adherence to timelines, budget, and quality standards.
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Act as the main sponsor liaison for CROs during study setup, execution, and closure.
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Ensure appropriate clinical contracts (e.g., Service Agreements) are executed and vendors are pre-qualified as Clinical Manager.
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Collect and evaluate CRO quotes, manage payments, and ensure work is performed per scope.
Documentation & Compliance
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Review and approve critical clinical documents: Study Protocols, ICFs, CRFs, Monitoring and Risk Management Plans, Statistical Analysis Plans, Safety Management Plans, etc.
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Maintain the Clinical Study Master List and Trial Master Files (both working and regulatory) as Clinical Manager.
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Ensure proper setup, monitoring, closeout, and archiving of trial sites and study documentation.
Quality Assurance & Safety
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Ensure compliance with GCP and regulatory requirements by overseeing in-house and remote monitoring.
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Ensure safety reporting is conducted per protocol and applicable standards.
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Support CAPA processes and manage study-related issues involving CROs, vendors, sites, and internal stakeholders.
Operational Management
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Design study feasibility plans aligned with molecule characteristics and applicable guidelines.
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Coordinate delivery and review of product samples for local Comparative Dissolution Profiles (CDPs) and clinical study batches as Clinical Manager.
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Track project progress and expenses, forecast budgets, and review vendor invoices for compliance with agreements.
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Organize and lead kick-off meetings, project updates, and cross-functional discussions.
Additional Responsibilities
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Participate in due diligence for in-licensing dossiers and provide clinical assessments.
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Perform statistical input for clinical studies when required.
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Support dossier preparation and review for global regulatory submissions.
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Undertake other responsibilities as assigned by senior management.
Key Requirements
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Advanced degree in Medicine, Pharmacy, Life Sciences, or related field (PhD or MD preferred) as Clinical Manager.
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Minimum 6–8 years of experience in clinical research, with at least 3 years in a clinical project or clinical management role.
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In-depth knowledge of ICH-GCP, regulatory frameworks (FDA, EMA, etc.), and global clinical development practices.
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Experience with complex generics, innovative dosage forms, and 505(b)(2) pathways is highly desirable.
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Strong cross-functional collaboration and stakeholder management skills.
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Excellent written and verbal communication.
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Ability to manage multiple projects with strict deadlines and limited supervision.
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Willingness to travel as required.
Core Competencies for Clinical Manager:
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Business Focus
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Drive for Results
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Building Team Spirit
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Customer Service
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Embracing Change
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Quality
Keywords: Clinical Manager, Healthcare, Adalvo, Patient Care, Leadership
