Associate Director, Project management - Late phase studies

14 Jan 2019
28 Jan 2019
Contract Type
ProClinical is seeking an Associate Director, Project Management to be office or home based across the EU, however we are particularly interested in applicants from UK, France, Germany, Switzerland and the Nordic region

This role will direct and manage large, global, multi-functional projects or program, including the execution of the clinical component of the project/program to the Sponsor’s satisfaction, ensuring quality deliverables, on time delivery and within budget. Has strategic decision-making responsibility for the project/program. Ensure that all project work is completed in accordance with SOPs, policies and practices.

Job Responsibilities:

* Manage the scope of work, objectives, quality of deliverables, and other project and study management activities.
* Serve as primary project/program contact with Sponsor to ensure appropriate communication channels are maintained and reporting schedules adhered to.
* Ensure the development of project plans for all phases of the project lifecycle, including the quality and risk management, ensuring that issue escalation and resolution is clear.
* Develop proactive contingency plans to mitigate clinical risk across studies.
* Work with Business Development to finalize the project/program budget and scope of work.
* Direct and lead project activities for team members related to their project-oriented tasks to ensure that project/program milestones are met.
* Continually review and make recommendations to ensure adequate resources are available to meet project deliverables and milestones
* Develop, lead and implement continuous improvement for assigned projects and programs.
* Act as the key relationship manager for assigned clients; recommend courses of action regarding client management issues; implement plan following approval by senior management.
* Ensuring adherence to change control processes.
* Provide consultation to clients on drug development process, study management strategy, and plans as needed.
* Participate in proposal and budget development, evaluate feasibility of potential programs and impact on company operations and goals, negotiate and make decisions on behalf of the organization. Participate in sales/proposal presentations in face-to-face meetings with potential clients.
* Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison.

Skills and Requirements:

* In depth clinical project management expertise along with a breath of therapeutic exposure and knowledge of study, project and drug development processes
* Experience of leading large, complex global Non-Interventional Studies in a Late Phase / Real World Evidence environment
* Demonstrated account management to develop sponsor relationships
* Demonstrated commercial skills such as proposal development, bid defence and project financial management skills
* In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
* Excellent communication and interpersonal skills, including good command of English language, strong influencing and negotiation skills
* Excellent organization, business judgement and problem-solving skills
* Strong presentation skills
* Ability to balance operational and strategic priorities
* Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
* Highly effective team leadership skills
* Bachelor's degree in life sciences or related field and a well-established career in international Non-Interventional clinical project management including leadership experience, leading complex multi-regional clinical projects; or equivalent combination of education, training and experience

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website -
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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