Startup Lead

Summary

Join Allucent™ as a Local Start-Up Lead (LSUL) and play a crucial role in managing clinical trial start-up activities at a country or regional level. You will oversee milestones, mitigate risks, and coordinate with various teams, including IRB/IEC/RA submissions, site contracts, and investigational product release. This hybrid/remote position requires strong communication, project management, and leadership skills. Responsibilities include planning timelines, managing budgets, ensuring client satisfaction, and contributing to process improvements. Allucent offers a comprehensive benefits package, including competitive salaries, professional development opportunities, flexible working hours, and remote work options.

Requirements

• Life science, healthcare and/or business degree
• Minimum 3 years of relevant work experience in study start-up and minimum 5 years of experience in drug development and/or clinical research; or equivalent combination of education, training, and experience
• Thorough knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements
• Strong written and verbal communication skills including good command of English language
• Ability to work in a fast-paced challenging environment of a growing company
• Working knowledge of project management processes
• Ability to translate guidelines, rules and regulations in clear and usable recommendations
• Administrative excellence
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Leadership skills
• Effective at problem solving and strategic thinking
• Strong presentation capabilities
• Excellent organizational, negotiating and financial skills

Responsibilities

• Attend the KOM and cover all aspects related to Study Start-Up activities when assigned as the only Start-Up Lead
• Coordinate IRB/IEC/RA submissions; work alongside the GRM/GSS and Local Start-up Specialist (LSUS) to ensure submissions are performed according to internal and client expectations
• Assist the Global Site Contract Manager to coordinate Site Contracts & Budgets; work alongside the LSUS to oversee the negotiations of contracts and budgets with sites and internal team according to the instructions agreed at the study level and obtain client approval on budget increase requests if outside the negotiation parameters
• Coordinate the Investigational Product Release Authorization (if applicable); work alongside the Global Essential Document Management Team and LSUS to meet client expectations for first patient in at study/country level
• Plan realistic timelines for submissions and first site activation at study level, day to day management during study start-up
• Oversee the SIS/ICF process & translations of study required documents (patient materials)
• Participate on the development of study specific plans for start-up; implement and monitor progress against project plans and revise as necessary
• Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
• Review study start-up budget and track out of scope budget activities
• Support Change Orders as needed and ensure any at risk work has received Senior Management approval
• May participate in RFP budget reviews and proposal text development
• May present at internal and/or external meetings including Bid Pursuit Meetings; prepare and deliver presentations in collaboration with relevant departments
• Appropriate issue escalation to applicable stakeholder(s)
• Serve as key client contact for assigned project(s), managing project milestones for start-up
• Draft and contribute as Subject Matter Expert (SME) in the field of Study Start-up activities to the evaluation/improvement of processes and procedures within the Quality Management System
• Monitor and assure client satisfaction on existing projects for the Study Start-up & Site Intelligence unit with related activities
• Assure professional communication and good relationships with (future) clients and stakeholders
• Contribute and take part in client evaluations, visits and bid defenses
• Support in preparation of new proposals
• Contribute to other areas of business as required

Preferred Qualifications

• Knowledge of contract negotiations process preferred
• Representative, outgoing and client focused

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms