Allucent ir konsultāciju un veselības aprūpes partneris, kas palīdz maziem un vidējiem biotehnoloģiju uzņēmumiem virzīt terapijas uz priekšu zāļu izstrādes procesā. Uzņēmuma pakalpojumi ietver klīnisko izstrādi, klīnisko farmakoloģiju, regulatīvo stratēģiju, zāļu drošumu un farmakovigilanci, atbalstot programmas no agrīnas izpētes un klīniskajiem pētījumiem līdz uzraudzībai pēc zāļu nonākšanas tirgū. Apvienojot vairāk nekā 30 gadu pieredzi ar zināšanām onkoloģijā, infekcijas slimībās, neiroloģijā, autoimūnās slimībās un retajās slimībās, Allucent palīdz biotehnoloģiju komandām risināt zinātniskos, regulatīvos un darbības izaicinājumus, kas saistīti ar jaunu ārstēšanas metožu ieviešanu tirgū.
Senior Clinical Project Manager, Europe
Lead end-to-end clinical trial delivery at Allucent, supporting biopharmaceutical companies as they bring therapies to patients. Coordinate teams, vendors, budgets, risks, and regulatory requirements.
Apraksts
- Direct the project team to deliver within agreed scope, timelines, and contract terms
- Develop and carry out project management plans
- Maintain quality and compliance with company policies, SOPs, work instructions, GCP, and regulatory guidance
- Set up stakeholder communications and escalation routes
- Contribute to study documents, including protocols, CRFs, medical review and monitoring plans, and clinical study reports
- Develop and manage training plans for each project
- Chair internal, sponsor, kickoff, and investigator meetings
- Assist with vendor identification, qualification, selection, and oversight
- Manage vendor relationships to support project delivery
- Allocate resources effectively across projects and programs
- Prepare, maintain, and distribute project status and progress reports
- Oversee study budgets and monthly invoicing
- Develop and oversee project risk management plans
- Identify and manage changes to project scope
- Negotiate with and influence internal and external team members
- Resolve project issues through strategic thinking and conflict resolution
- Keep the Trial Master File current and ready for inspection
- Act as the main point of contact between the sponsor and project team
- Set a strong example and promote effective clinical trial delivery
- Oversee team delivery and communication with functional managers, including performance feedback
Prasības
- Bachelor’s degree in life sciences, healthcare, or business
- At least 5 years of relevant work experience
- At least 5 years in drug development or clinical research, including 3 years managing clinical trial projects
- CRA experience is preferred
- Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable local regulations
- Strong financial, administrative, and analytical skills
- Experience managing the full-service clinical trial lifecycle, including start-up, maintenance, and close-out
- Excellent written and verbal communication, planning, critical thinking, and organizational skills, with fluent English
- Representative, outgoing, and client-focused approach
- Ability to work effectively in a fast-paced, challenging environment at a growing company
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Strong presentation skills
- Commitment to learning and developing others
- Dependable, with the ability to respond quickly to urgent needs
- Proactive and solution-oriented approach
- Willingness to take ownership and drive positive, collaborative outcomes with the project team
- Sound judgment in applying procedures and policies to determine appropriate actions
Priekšrocības
- Benefits package tailored to location
- Competitive salary based on location
- Departmental study and training budget for professional development
- Flexible working hours, within reason
- Remote or office work options depending on location
- Leadership and mentoring opportunities
- Buddy Program for new and existing employees
- Internal development and career progression opportunities
- Employee referral program with financial rewards
- Online soft-skills and technical training through ADP and internal platforms
- Dynamic working environment, with two office days per week for employees within reasonable distance of a global office