The Project Director is responsible for oversightof the conduct of a program or portfolio of clinical studies orlarge global multicentered trials with large study budgets. Theportfolio may comprise studies for specific customers, and / or agroup of studies within the same therapeutic area or indication formore than one customer. The Project Director oversees ProjectManagers (PMs) who are managing projects ranging in size andcomplexity from single service studies to large full scope,multiple protocol projects, global projects and / or portfolio ofprojects. The Project Director leads the operational contributionto proposal development and business development activities at aproject level with minimal oversight directly applying theirtherapeutic and project management expertise.
This role will be perfect for you if :
- You are looking to contribute your expertise to thegrowth of a specialized CRO.
- You are ahands-on leader.
- You want to be involved inprogram management as well as line management.
RESPONSIBILITIES
Oversees a portfolio or program of projects and theProject Managers assigned to operationalize the awardedstudies.Ensures all studies within a programor portfolio are conducted to reflect the therapeutic or clientspecific requirements.Represents company tothe customer, ensuring satisfaction levels are maintained andprogram deliverables are communicated effectively.Ensures the study is progressing according to internaland Customer quality standards, Standard Operating Procedures(SOPs), Good Clinical Practices (GCPs) or appropriate regulatoryrequirements, and International Conference on Harmonization (ICH)guidelines to fulfil all federal and local regulations.Oversees the management of the executed contract andfinancial aspects of assigned projects, including reviewing studybudgets and expenses.Maintains and evaluatesproject progress by maintaining timelines and othertracking / analysis tools.Ensures and maintainsan in depth therapeutic and / or client specific knowledge andexpertise for the assigned portfolio.Appliesstudy specific learning across assigned portfolio ofstudies / clients.Leads and ensures consistencyin contingency planning and risk mitigation strategies to ensuresuccessful delivery.May lead operationalinput to proposal development and pricing including proposedoperations strategy.Drives performanceimprovement, operational efficiencies and innovativestrategies.May provide line managementoversight and contribute to leadership of Project Management as anoperational and therapeutic area expert.Our Company : The Work Environment
AtInnovaderm, you will work with brilliant and driven colleagues. Ourvalues are collaboration, innovation, reliability, andresponsiveness. We offer a stimulating work environment andattractive advancement opportunities.
WorkLocation
Note that this opening is for ahome-based position in Germany. Regular travel, which may includeovernight trips and / or international travel, is required as part ofthis role.
About Innovaderm
Innovaderm is a contract research organization (CRO)specialized in dermatology. Since its beginnings in 2000, ourorganization has benefited from a solid reputation for the qualityof its research and services exceeding the expectations of itsclients. Based in Montreal, Innovaderm continues to grow and expandin North America and Europe.
Innovaderm iscommitted to providing equitable treatment and equal opportunity toall individuals. As such, Innovaderm will provide accommodationsthroughout the recruitment and selection process to applicants withdisabilities, upon request. Innovaderm only accepts applicants whocan legally work in Germany.
IDEALPROFILE
Education
Bachelor of Science in a relevantdiscipline.A Master’s degree is anasset.PMP or PRINCE2 Certification is anasset.Experience
At least 15 years industry experience and aminimum of 5 years at a CRO.At least 10 yearsof clinical project management experience, including management ofall project phases from start up to closure, management of allfunctional services, vendor management.Experience with mid-size and large studies (>10-15countries) in multiple regions (NA, SA, APAC, MENA, Europe) isdesirable.
Experience leading concurrentmulti-centered, multinational phase III clinical trials includingproject budget financial tracking and forecasting.Substantial experience in project supervision, mentoringand coaching project managers.Substantialexperience with business development tasks, such as development ofproposals, client presentations, bid defense meetings, and thelike.Participation in mentoring and coachingof a representative number of project managers.Line management experience is desirable.Dermatology experience is an asset.Knowledge and Skills
Good knowledge of good clinical practices, and applicable HealthCanada and Food and Drug Administration (FDA)regulations / guidelines.
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