Project Manager, Site Selection & Activation, Clinical R&D
Major CRO - Rolling Client Contract
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 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 regulatory 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 you may want to apply for these roles.
Oversight of project Study Start Up (SSU) activities from site selection through site activation-ready.
Responsibility on cross-functional SSU deliverables.
Primary regional liaison during SSU.
Management of multifunctional leads associated with SSU, 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
Monitors scope. variations and implications on cost and resources. Drives efficiency and profit.
Pricing and bid defense contributions
Training of executives staff
Controls document management and^regulatory ready compliance
Essential Skills & Qualification
Degree in the science/health care field, legal degree, 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 potentially in multiple countries.
Good understanding of the regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release^requirements in own country plus one other country in the same region.
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
Contract Term: 6-12 Months
Registration, Regulatory Affairs, MAA, Clinical Trial Applications, CTA, CPMP, Dossier, Regulatory Agency, Documentum, EU, start up, SSU, Degree, science, clinical trial, project management, EU, Surrey, Brussels,Sofia, Prague, Paris, Langenfeld, Munich, Budapest, Tel-Aviv, Milan, Saronno, Warsaw, Bucharest, Moscow, St. Petersburg, Belgrade, Barcelona, Madrid, Uppsala, Amsterdam or Utrecht
Assigned Consultant:Gabrielle Gainsborough at CSL Recruitment on 01932 228928.
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.