Clinical Project Manager, Late Phase
Major CRO - Permanent role in Munich, Germany or Surrey, UK
Office or Home based
Are you an experienced project manager with a strong track record in running late phase studies? My client, a leading CRO specialising in providing a full range of phase I to IV clinical development services across six continents, is looking for a talented project manager to join their late phase team either in Germany or the UK. Experience in managing phase IV cardiovascular or endocrinology studies is particularly desirable.
They are a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical^and biotechnology companies look to them for a complete range of customized Phase I - Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials.
Summary of Responsibilities
Customer focused leadership in managing late phase clinical trials
Responsible for the successful execution of all assigned projects, on-time, on-budget, and high quality/compliant project results that lead to satisfied customers.
An integral part of the selling team^through involvement in proposal development and bid defence.
Primary liaison with Customers, vendors, and Investigator Sites.
May have line management responsibility for assigned clinical staff.
Manages projects from proposal development to final deliverables to the customer ranging in size and complexity from single service studies to full scope, multiple protocol projects, which may be global, with limited interaction from supervisor.
Essential Skills & Qualification
BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience.
Moderate clinical research experience in a contract research organization, pharmaceutical, or Biotechnology Company. Clinical research organization (CRO) and relevant therapeutic experience preferred.
Previous technical and managerial experience in conducting multi-national and/or local clinical trials in a hospital setting, pharmaceutical company, or CRO preferred.
Thorough knowledge of regulatory requirements, drug development, and clinical monitoring procedures. Demonstrated proficiency with ICH/GCP guidelines.
Keen insight, independent judgment, and tactful discretion. Presentation, documentation, and interpersonal skills as well as a team-oriented approach.
Proficient computer skills in Word, Excel, PowerPoint, email and Internet. Basic computer skills using MS Project.
Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic^environment.
Good communication and interpersonal skills.
Strong written and spoken English.
Ability to work independently.
Supplementary Requirements:
Software Competence: MS Office, MS Project, Excel
Valid Driving License: Desirable
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: Yes
Employment Information: Permanent
Employer: Global CRO
Employment Type: Client Contract
Hours: Full time
Keywords:
Clinical Research, Clinical^Operations, Clinical R&D, GCP, Study Manager, EUCTD, ICH GCP, Project Manager, Clinical Study, Clinical Programme, Essential Documents, Training, Investigator Meeting, REC, Research, protocol, Budget, vendor, RFP, variation, scope, CRO, Contracts, Clinical Trial Agreements, C&O. Bids, Proposals, Negotiation, , Financial, Phase IV, late phase, clinical trial, project management, Surrey, Munich
Assigned Consultant: Sue Spice 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.