Local Start Up Lead (Canada)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Local Start Up Lead (LSUL) to join our A-team (hybrid*/remote). As a LSUL at Allucent, you will oversee and manage the Start-Up Activities at a country or regional level, supporting the Local Start-Up project team assigned during the start-up phase. The Local Start-up Lead is responsible and accountable for keeping the Study Start-Up Milestones on track during the course of the study(s), thereby ensuring that expectations are met while identifying and mitigating the start-up risks

In this role your key tasks will include:

• When assigned as the only Start-Up Lead, attend the KOM and cover all aspects related to Study Start-Up activities.
• Coordinate IRB/IEC/RA submissions: will 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: will 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): will 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

To be successful you will possess:

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

Knowledge of contract negotiations process preferred

Strong written and verbal communication skills including good command of English language

Representative, outgoing and client focused

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

Benefits of working at Allucent include:

• 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

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

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