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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in contract management and clinical trial conduct, ensuring compliance with ICH/GCP guidelines and regulatory requirements. Proficient in developing process improvements and providing strategic legal advice within the pharmaceutical industry.
Highest-signal resume keywords
Contract Management ExperienceKnowledge Of ICH/GCP GuidelinesClinical Trial ConductProcess Improvement InitiativesStrong Negotiation Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Contract ManagementClinical Trial ConductProcess ImprovementRegulatory ComplianceAnalytical Problem SolvingDecision-MakingLegal AdviceNegotiationSOP DevelopmentData Privacy Knowledge
Soft Skills
Communication SkillsInterpersonal SkillsTeam DevelopmentJudgmentAdministrative Skills
Industry Keywords
Pharmaceutical IndustryGlobal TrialsGDPR ComplianceClinical OperationsContract Negotiation
About the role
Key responsibilities & impact- Oversee site contracting performance and strategy across a defined portfolio of studies or customers
- Ensure contracting is delivered predictably, efficiently, and in line with business and customer expectations
- Manage day-to-day contract management activities and support the team to deliver quality outcomes
- Manage and may lead day-to-day operations within the relevant support function in compliance with GCP/ICH guidelines and regulatory requirements
- Communicate and coordinate with key business stakeholders, including study teams, to support timely completion of drug and non-drug program goals and objectives
- Implement standards for designated functional areas
- Manage and provide operational support for the global study operating model, including business processes and service-provider operating models
- Optimize internal and external business process standards for Clinical Operations
- Provide oversight and direction to team members for contract escalations
- Proactively identify, risk-manage, escalate, and resolve issues arising with clinical site contracts
- Develop and continuously update functional SOPs, the Astellas Global Contract Negotiations Playbook, and other relevant processes and tools
- Liaise between site contract negotiators and designated legal partners to support global templates and processes and provide timely, strategic legal advice
Requirements
What you’ll need- BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree
- Solid contract management experience
- Ability to manage competing priorities and develop your team
- Knowledge of clinical trial conduct, including, multi-center, global trials
- Strong knowledge of ICH/GCP guidelines and regulatory requirements
- Good understanding of regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to core and country templates
- Experience with development & implementation of process improvement related initiatives
- Strong analytical problem solving and decision-making skills
- Ability to exercise sound judgment and provide practical and constructive legal advice
- Strong negotiation and communication skills, both oral and written
- Ability to communicate legal issues clearly and understandably
- Excellent interpersonal, written and verbal communication skills
- Administrative skills and computer ability
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways