Clinical Manager at Adalvo – Lead Global Clinical Trials, Apply Now!
Looking for your next big career move in clinical research? Adalvo is seeking a passionate and skilled Clinical Manager to join our fast-growing, dynamic team. In this exciting role, you’ll manage global clinical trials, provide scientific and regulatory input, and work closely with cross-functional teams to drive innovative healthcare solutions. If you have a strong clinical research background and thrive in a high-energy environment, Adalvo could be your perfect next step.
About the Company
At Adalvo, we’re not just a company – we’re a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, fast and always on target, we are Adalvo!
Organization Structure: The position will report directly to our Director, Clinical
Responsibilities
Clinical Strategy & Product Development
-
Provide expert clinical input during product selection and pipeline development, including for complex generics and 505(b)(2) applications.
-
Develop clinical strategies and feasibility plans for new and differentiated products.
-
Propose innovative approaches and clinical waiver strategies for regulatory efficiency.
-
Contribute to the ideation and evaluation of new products alongside Business, R&D, and Portfolio teams.
Regulatory & Scientific Documentation
-
Prepare and review clinical synopses, protocols, and scientific advice documentation.
-
Provide clinical inputs for briefing books and controlled correspondence to health authorities (US-FDA, EMA, APAC).
-
Assist in drafting responses to regulatory queries and provide clinical support for IP litigations.
Study Oversight & Vendor Management
-
Manage the full lifecycle of assigned studies (BA/BE, PK, Phase III, patient-based trials), ensuring adherence to timelines, budget, and quality standards.
-
Act as the main sponsor liaison for CROs during study setup, execution, and closure.
-
Ensure appropriate clinical contracts (e.g., Service Agreements) are executed and vendors are pre-qualified.
-
Collect and evaluate CRO quotes, manage payments, and ensure work is performed per scope.
Documentation & Compliance
-
Review and approve critical clinical documents: Study Protocols, ICFs, CRFs, Monitoring and Risk Management Plans, Statistical Analysis Plans, Safety Management Plans, etc.
-
Maintain the Clinical Study Master List and Trial Master Files (both working and regulatory).
-
Ensure proper setup, monitoring, closeout, and archiving of trial sites and study documentation.
Quality Assurance & Safety
-
Ensure compliance with GCP and regulatory requirements by overseeing in-house and remote monitoring.
-
Ensure safety reporting is conducted per protocol and applicable standards.
-
Support CAPA processes and manage study-related issues involving CROs, vendors, sites, and internal stakeholders.
Operational Management
-
Design study feasibility plans aligned with molecule characteristics and applicable guidelines.
-
Coordinate delivery and review of product samples for local Comparative Dissolution Profiles (CDPs) and clinical study batches.
-
Track project progress and expenses, forecast budgets, and review vendor invoices for compliance with agreements.
-
Organize and lead kick-off meetings, project updates, and cross-functional discussions.
Additional Responsibilities
-
Participate in due diligence for in-licensing dossiers and provide clinical assessments.
-
Perform statistical input for clinical studies when required.
-
Support dossier preparation and review for global regulatory submissions.
-
Undertake other responsibilities as assigned by senior management.
Key Requirements
-
Advanced degree in Medicine, Pharmacy, Life Sciences or related field (PhD or MD preferred).
-
Minimum 6–8 years of experience in clinical research, with at least 3 years in a clinical project or clinical management role.
-
In-depth knowledge of ICH-GCP, regulatory frameworks (FDA, EMA, etc.), and global clinical development practices.
-
Experience with complex generics, innovative dosage forms, and 505(b)(2) pathways is highly desirable.
-
Strong cross-functional collaboration and stakeholder management skills.
-
Excellent written and verbal communication.
-
Ability to manage multiple projects with strict deadlines and limited supervision.
-
Willingness to travel as required.
SEO Keywords: Clinical Manager, Adalvo, Jobs, Clinical Trials, Regulatory Compliance, Clinical Documentation, Vendor Management
