Manager, Study Start Up and Regulatory Affairs

ERGOMED

. Develop regulatory strategies and coordinate and oversee study start-up deliverables from site selection through site initiation readiness .

Posted 11/11/2026full-timeRemote • United KingdomMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in developing regulatory strategies and managing study start-up processes for medium- to high-complexity projects, with a strong focus on compliance, risk mitigation, and stakeholder relationship management.

Highest-signal resume keywords

Regulatory Strategy DevelopmentStudy Start-Up ManagementClinical Site Agreement NegotiationRisk Identification and MitigationProject Budget Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Requirements KnowledgeClinical Study Start-Up ProcessesDocument Collection and ComplianceProject ManagementGlobal Project Management

Soft Skills

Coaching and GuidanceRelationship BuildingPerformance Feedback

Industry Keywords

Pharmaceutical IndustryCRO IndustryClinical TrialsBusiness DevelopmentProposal Development

About the role

Key responsibilities & impact

Develop regulatory strategies and coordinate and oversee study start-up deliverables from site selection through site initiation readiness
Lead study start-up and regulatory activities for assigned medium- to high-complexity projects
Manage end-to-end study start-up and regulatory milestones
Collect, review, track, and resolve issues with essential study documents
Prepare study team reports and updates on document collection, review, and approval status
Negotiate and execute clinical site agreements, ancillary agreements, and amendments
Identify, assess, and mitigate risks affecting study start-up and regulatory timelines
Build and maintain relationships with clients, regulatory authorities, and internal stakeholders
Assign departmental deliverables, monitor budgets and hours, and escalate out-of-scope work
Participate in business development meetings and contribute to proposals, regulatory sections, costings, and budgets
Provide strategic input into bids and support winning new business
Provide coaching, guidance, and performance feedback to team members
May line manage staff and perform other assigned duties

Requirements

What you’ll need

Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience
6–8 years within the pharmaceutical or CRO industry or a regulatory body
At least 3 years in a leading/project management role
Proven ability to successfully manage global projects
Knowledge of regulatory requirements and clinical study start-up processes
Experience with site selection through site initiation readiness
Ability to manage study start-up and regulatory activities for medium- to high-complexity projects
Ability to oversee essential document collection, review, compliance, and tracking
Ability to negotiate and execute clinical site agreements, ancillary agreements, and amendments
Ability to define and implement study start-up and regulatory strategies
Risk identification, assessment, and mitigation skills
Ability to monitor project budgets and identify out-of-scope work
Experience contributing to business development meetings, proposals, regulatory costing, and budgets

Benefits

Comp & perks

Collaborative, international team environment
Career growth opportunities
Flexible work culture
Work-life balance
Coaching, guidance, and mentoring opportunities
Passionate and collaborative team of experts
Inclusive workplace where every voice counts