Regional Study Start-Up Lead

Biogen, Inc.; Schweiz; Vor Ort; EUR 129.000 - 193.000; Vollzeit

Zusammenfassung

Biogen, Inc. is seeking a Regional Study Start-Up Lead to manage site activation across EUCTR and APAC regions. You’ll drive site selection, oversee timelines, and coordinate with SSU specialists to ensure timely, compliant activations.

Strong communication and leadership are essential as you interact with country teams and regulators. The role requires extensive experience in study start-up, CRO environments, and proficiency with CTMS/eTMF tools, enabling effective management of multi-study

Qualifikationen

• Bachelor’s degree in life sciences or equivalent.
• Minimum of 8 years of clinical trial experience, with at least 5 years in a study start-up role and at least 3 at a regional level.
• Experience in a CRO and strong EUCTR submissions knowledge.
• APAC region start-up experience is essential.

Aufgaben

• Lead day-to-day management of multiple site-activation projects.
• Drive site selection and activation within your region.
• Ensure timelines and quality standards for EC/Regulatory submissions.
• Coordinate SSU specialists across regions and monitor critical path.
• Provide escalation support for regulatory or vendor issues.
• Communicate activation strategy to country teams and monitor progress.

Kenntnisse

EUCTR experience

APAC experience

Project management

Site activation

Cross-functional leadership

English communication

CTMS

eTMF

Veeva

Microsoft Project

Ausbildung

Bachelor’s Degree in life sciences or equivalent

Tools

CTMS

eTMF

Veeva

Microsoft Project

Jobbeschreibung

## Regional Study Start-Up LeadApplyremote type: Hybridlocations: Baar, Switzerlandtime type: Full timeposted on: Posted Todayjob requisition id: REQ23858**Job Title:** Regional Study Start-Up Lead**About This Role:** As a Regional Study Start-Up Lead, you will play a pivotal role in managing the effective delivery of site activation within your designated region(s). For this particular role you will be required to have expert knowledge in EUCTR and APAC regions. This position is crucial in overseeing site activation according to prescribed timelines and quality standards, while coordinating closely with SSU Specialists. You will be responsible for managing technical and operational aspects to ensure successful site selection and activation. Your leadership will be instrumental in driving site selection efforts, communicating strategies to country teams, and monitoring progress to maintain alignment with business goals. By spearheading these initiatives, you contribute significantly to our overarching mission of delivering high-quality clinical trials and advancing healthcare solutions.**What You’ll Do:*** Lead day-to-day management of multiple projects or a multi-study program for site activation.* Drive site selection processes within your region to ensure timely and efficient activation.* Oversee site activation according to timelines and quality standards across a region.* Communicate site activation strategy to country teams and monitor progress.* Act as a SME in EUCTR ensuring timely collection of part 2 documents for all countries and sites that you are overseeing.* Ensure that all EC’s and Regulatory authorities have been paid in an appropriate timeframe* Coordinate SSU specialists across regions and ensure all sites within regions are on track with the critical path site activation plan.* Serve as an escalation point for issues identified by SSU specialists, including regulatory and vendor setup issues.* Monitor project status, identify risks, and provide metrics to Study Start-up Oversight Lead.* Ensure that Oversight Lead is aware of any risks to study timelines and develop appropriate mitigations.* Facilitate knowledge transfers across countries within regions.* Collaborate with other Regional/Oversight Leads to resolve issues and ensure activation activities adhere to the agreed plan.* Oversee EC submission strategy and required documents: patient facing materials: ICF’s, questionnaires etc* Manage country and site Informed Consent Form (ICF) timelines; review and approve country ICFs.* Provide quality checks for EC submission packages for both central and local ECs.* Provide quality checks of essential documents and essential document packages* Ensure operational readiness for site activation in collaboration with CML, including site binders, ancillary supplies, lab kits, training, and system access.* Coordinate information flow between key stakeholders involved in site activation and ensuring that site activation form is signed off in a timely maner* Ensure consistency and application of processes within studies.* Initiate and execute study-related progress reports.* Provide oversight and management of amendment implementation as needed.**Who You Are:** You thrive in dynamic environments, demonstrating an ability to manage multiple projects and coordinate cross-functional teams with ease. Your strong communication and leadership skills enable you to effectively influence stakeholders and drive results. You possess a proactive mindset, always looking to identify bottlenecks and propose innovative solutions. Your experience in clinical trials, particularly in study start-up roles at a regional level, equips you with the expertise needed to navigate complex challenges. You are detail-oriented and adept at handling a high volume of tasks, ensuring that priorities are met in a timely manner.**Required Skills:*** Bachelor’s Degree in life sciences or equivalent (e.g., pharmacy, nursing).* Minimum of 8 years of clinical trial experience, with at least 5 years in a study start-up role and at least 3 at a regional level.* Previous experience in a Contract Research Organization (CRO) is essential.* Strong EUCTR experience – previously involved in submissions.* Experience of start up in APAC region* Proven experience in project management and site activation.* Strong communication, organizational, and leadership skills.* Proactive mindset with the ability to identify bottlenecks and propose solutions.* Ability to manage multiple projects, coordinate cross-functional teams, and work in a matrix environment.* Proven ability to handle a high volume of tasks of varying complexity and effectively utilize escalation pathways.* Excellent communication skills (listening, oral, written) in English.* Comfortable using CTMS, eTMF, Veeva, and Microsoft Project.**Preferred Skills:*** Familiarity with regional regulatory processes and requirements.* Experience in leading cross-functional teams effectively.* Advanced proficiency in project management tools andJob Level: Management