Associate Director, Site Selection & Activation, Clinical R&D
Major CRO, permanent position
EU Locations including Surrey, Brussels, Sofia, Prague, Paris, Langenfeld, Munich, Budapest, Tel-Aviv, Milan, Saronno, Warsaw, Bucharest, Moscow, St. Petersburg, Belgrade, Barcelona, Madrid, Uppsala, Amsterdam or Utrecht
Are you frustrated with the amount of travel your current role demands? Then this role may be for you, focussing on managing a team responsible for study start up activities, this^role will rely on process efficiency and expediting the whole study start up process.
Our client has a very busy time ahead and needs capacity to help ensure new trials are initiated well and in a compliant manner. They have office based openings^in several countries and can consider people who have expertise in start up or study management for these roles. If you are a proficient study manager with solid knowledge of the market, research ethics, investigator agreement/contracts and the regulatory environment this could be the role for you.
Oversight of project Study Start Up activities from site selection through site activation-ready.
Responsibility on cross-functional deliverables.
Primary regional liaison during start-up.
Management of multifunctional leads associated with study start-up, such as but not limited to:
Site identification and qualification;
Clinical trial regulatory (submissions, communication to competent authorities/ethics committees import licences, study maintenance submissions);
Essential document collection leading to site activation;
Site contract management;
Overall SSU timelines to site activation
Contingency planning and risk management to achieve budget, timelines^and quality demands
Schedules PSV and SIVs
Monitoring scope. variations and implications on cost and resources. Driving efficiency and profit.
Pricing and bid defense contributions
Training of clinical staff
Essential Skills & Qualification
Degree in the science/health care field or equivalent combination of education and experience.
Some formal project management training or certification (e.g., PMP) preferred.
Clinical research experience that includes submissions and leading studies in multiple countries.
Good understanding of the regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release requirements in at least two countries
Some experience of line management, ideally across countries
Good understanding of major areas in clinical development.
Good communication and interpersonal skills.
Strong written and spoken English.
Proficient in the use of computer and software systems (e.g., Excel, MS^Project).
Demonstrated ability to receive and transmit the appropriate volume of information in a timely manner with the correct messages across various contexts, cultures, channels, and media. Ability to work independently.
Software Competence: MS Office, MS Project, Excel
Valid Driving License: Desirable
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: Yes
Employer: Global CRO
Employment Type: Client Contract
Hours: 0.75 - 1.0 FTE
Keywords: Clinical study management, Clinical study start-up, Clinical Trial Applications, CTA, , Dossier, EU, start up, SSU, clinical trial, project management, clinical research, clinical investigator CRO, SMO, EU, Surrey, Brussels,Sofia, Prague, Paris, Langenfeld, Munich, Budapest, Tel-Aviv, Milan, Saronno, Warsaw, Bucharest, Belgrade, Barcelona, Madrid, Uppsala, Amsterdam or Utrecht
Assigned Consultant: Avril Horn at CSL Recruitment on^0193234686
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role requires in their application. The^role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.