The role manages large regional and global safety projects, covering one or several Lifecycle Safety functions in clinical trials, post-market work, or both.
You lead customer-facing work and oversee service delivery, linking every stage of the opportunity so the customer gets one coherent, transparent program. Accounts are used to group that work.
You may work with the global management team and integrated partners on strategic initiatives that grow the business, deepen partnerships, and keep practice consistent worldwide.
Responsibilities
Act as the main contact for Lifecycle Safety with internal and external customers on assigned projects and programs, and link them to the Lifecycle Safety operational teams.
Lead day-to-day customer delivery, covering project plans, timelines, deliverables, scope, quality, and project finances.
You may own an account or customer portfolio, report program or portfolio metrics, and oversee projects you do not lead directly.
Act as solution architect for new standalone Safety opportunities: build and defend proposed solutions, set operating budget assumptions, decide how the budget is shaped, and tailor text and data.
Serve as the Safety subject matter expert and single point of contact for governance, executives, and integrated partners on proposals, defending strategy and pricing from initiation through delivery.
Lead customer-facing materials and operational support so key Lifecycle Safety messages appear in collateral, presentations, and meetings, working with senior leaders on initiatives.
Lead the customer service structure from scoping through proposal, bid defense, transition, and service delivery, across the product's development and commercial life.
Manage finances for assigned work: financial system updates, revenue recognition, invoicing, budget review, financial analysis, and change orders.
Track key performance measures such as revenue, direct costs, timesheet costs, and contribution margin.
Build specialist expertise and act as subject matter expert on departmental, regional, or global initiatives.
Work with sales and proposals to produce fast, seamless, tailored responses, and grow business by strengthening loyalty, relationships, and communication.
Start new projects using standard procedures and best practice, identifying risks at initiation and putting mitigations in place for smooth handover to maintenance.
Run meetings with internal and external stakeholders, give status updates, and set process and planning direction.
Lead the virtual local and global Lifecycle Safety project teams, keep them informed, and review process and status in team meetings with operational teams.
Support sales with presentations, bid defenses, and proposal strategy, costs, and text.
Bring strategic options into project and program scope and process definitions agreed with the customer.
Turn customer relationships into partnerships, manage accounts for long-term business, and lead discussions on new opportunities with existing customers.
Study current and future customer needs and develop cross-functional strategic solutions within Lifecycle Safety service lines.
Take part in client and internal audits and inspections, and work with Quality Assurance to draft corrective action plans.
Work with Lifecycle Safety management to resolve problem areas and customer needs while keeping practice consistent globally.
Requirements
A bachelor's degree in health science or a directly related field, or equivalent experience.
4 to 6 years of clinical research experience at a contract research organization or pharmaceutical company, including 4 years in Lifecycle Safety (such as pharmacovigilance, CEVA, medical information, safety publishing, or risk management) and 2 years in project management.
Strong knowledge of global, regional, and local clinical research regulations, including GCP and ICH guidelines and the company standard operating procedures.
Working knowledge of Lifecycle Safety service lines, with a willingness to widen that knowledge and build new skills.
Strong team management, leadership, and conflict management skills.
Strong project management, planning, and organizing skills.
Clear verbal and written communication, including networking and leading teleconferences.
Good collaboration, organization, and delegation skills.
Ability to build and sustain working relationships with colleagues, managers, and customers.
Ability to deliver several projects at once and balance competing priorities.
Business focus, marketing, and sales skills.
Proven ability to present well, write reports, and focus on the customer.
Ability to get results through communication, facilitation, and negotiation in a matrix delivery setting with shared accountability.
Sound independent judgment, negotiation, decision-making, and problem solving.
Business acumen, financial analysis, tactical planning, and budgeting skills.
Relationship building and a customer-focused approach.
Skill at motivating, influencing, and resolving conflict.
Conditions
Base pay ranges from $86,000.00 to $214,800.00 per year, annualized.
Actual pay depends on factors such as qualifications, location, and whether the role is full or part time.
Incentive plans, bonuses, or other compensation may be offered depending on the position, along with health, welfare, and other benefits.
The company is committed to integrity in hiring and has zero tolerance for candidate fraud; all application information must be truthful and complete, and false statements or material omissions may lead to disqualification or dismissal under applicable law.
Benefits
Incentive plans, bonuses, or other compensation may be offered, along with health, welfare, and other benefits.