Responsible for developing the strategy based on regulatory requirements and for coordinating and overseeing all SSU deliverables from site selection through site initiation readiness.
Responsibilities
Leads study start-up and regulatory activities for assigned projects of medium to high complexity
Accountable for end-to-end delivery of study start-up and regulatory milestones across assigned projects
Ensure collection, review for completeness/compliance, and tracking of essential documents for Study Start-Up
Ensure negotiation and execution of clinical site agreements, ancillary agreements as well as amendments
Defines and implements study start-up and regulatory strategies at project level
The Manager, Study Start Up and Regulatory Affairs is responsible for developing the strategy based on regulatory requirements and for coordinating and overseeing all SSU deliverables from site selection through site initiation readiness.
Responsibilities
Develop strategy based on regulatory requirements
Coordinate and oversee all SSU deliverables from site selection through site initiation readiness
Assist senior management in securing new business by participating in BDMs and contributing to proposals/budgets
Provide strategic regulatory guidance, training, coaching and mentoring to junior members
Line manage members of staff
Requirements
Graduate degree in Chemistry or Life Sciences, Nursing or equivalent
The Manager, Study Start Up and Regulatory Affairs is responsible for developing the strategy based on regulatory requirements and for coordinating and overseeing all SSU deliverables from site selection through site initiation readiness.
Responsibilities
Develop strategy based on regulatory requirements
Coordinate and oversee all SSU deliverables from site selection through site initiation readiness
Assist senior management in securing new business by participating in BDMs and contributing to proposals/budgets
Provide strategic regulatory guidance, training, coaching and mentoring to junior members
Line manage members of staff
Requirements
Graduate degree in Chemistry or Life Sciences, Nursing or equivalent
Responsible for developing the strategy based on regulatory requirements and for coordinating and overseeing all SSU deliverables from site selection through site initiation readiness. Also assists senior management in securing new business and provides strategic regulatory guidance, training, coaching and mentoring to junior members.
Responsibilities
Leads study start-up and regulatory activities for assigned projects of medium to high complexity
Accountable for end-to-end delivery of study start-up and regulatory milestones across assigned projects
Ensure collection, review for completeness/compliance, and tracking of essential documents for Study Start-Up
Ensure negotiation and execution of clinical site agreements, ancillary agreements as well as amendments
Defines and implements study start-up and regulatory strategies at project level
Requirements
Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience
Manager, Feasibility and Site Activation (FSA) leading teams responsible for delivering high-quality feasibility assessments and efficient site activation for global clinical trials.
Compensation
Competitive base salary and performance related incentives
Responsibilities
Managing FSA project teams to deliver country and site feasibility, start-up strategies, and activation activities in line with timelines and quality expectations
Overseeing the coordination of essential documents, regulatory and ethics submissions, and contract/start-up packages for assigned studies
Reviewing feasibility data, assumptions, and risks, and partnering with stakeholders to develop mitigation plans and realistic start-up forecasts
Collaborating with business development and operational teams to support proposals, bid defences, and customer meetings with robust FSA input
Monitoring performance metrics for feasibility and site activation, identifying trends and driving continuous improvement initiatives
Requirements
Bachelor's degree in life sciences, healthcare, business, or a related field
Lead end-to-end delivery of complex clinical study programs for pharmaceutical/biotech clients, serving as the primary client contact and ensuring compliance with regulatory and quality standards.
Compensation
The salary range estimated for this position based in Maryland is $75,000.00–$112,500.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
Responsibilities
Lead and manage full lifecycle clinical trial projects (start-up, conduct, close-out) for pharmaceutical/biotech clients
Act as the primary client-facing point of contact, building strong, consultative relationships
Drive study timelines, deliverables, and budgets while ensuring adherence to GCP, FDA, and ICH guidelines
Oversee cross-functional teams (clinical operations, labs, data management, supply chain, etc.) in a matrix environment
Proactively identify risks, develop mitigation strategies, and escalate issues appropriately
Requirements
High school diploma or GED required
Bachelor’s degree preferred (Life Sciences or Project Management preferred; e.g., Biology, Chemistry, Clinical Research, or related field)
Nice to have: PMP certification or equivalent
Nice to have: experience in a central lab, biomarker, or clinical services environment
Nice to have: prior experience in a client-facing or sponsor-facing role
Support ongoing clinical development programs within Rare Diseases, focusing on Pediatric Growth Hormone Deficiency and related endocrine disorders, acting as a field-based liaison to clinical trial sites, investigators, and stakeholders.
Locations (2)
Argentina
Colombia
Compensation
Amplity offers a competitive salary, comprehensive benefits package, and opportunities for long-term professional growth.
Responsibilities
Serve as a scientific and operational liaison between clinical trial sites and study teams
Support study start-up, site activation, patient recruitment, enrollment, and retention activities
Build and maintain strong relationships with investigators, study coordinators, referral centers, and research staff
Support sites in identifying and addressing recruitment barriers and enrollment challenges
Assist sites with patient identification strategies and referral pathway development
Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager.
Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.
Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
Support the Study Start Up Team Lead in developing and executing the plan for country and site distribution, conducting feasibility assessments, site identification, contract negotiation, and ensuring regulatory compliance for clinical trials.
Compensation
Competitive base salary and performance related incentives
Lead the planning and execution of European Union Clinical Trials Regulation Part II submissions throughout the study lifecycle.
Responsibilities
Lead the planning and execution of EU Clinical Trials Regulation Part II submissions
Partner with Clinical Trial Management and Regulatory Affairs to define country allocation, submission strategy, breakthroughs, and timelines
Coordinate Member State, institution, principal investigator, and site-level information and documentation required for clinical trial applications
Prepare and maintain accurate submission content in the Clinical Trials Information System and ensure alignment with national requirements
Collaborate with Clinical Transparency on document redactions and collect compliant documentation for In Vitro Diagnostic Regulation ethics submissions