ID-Clinical - personnel resourcing specialists for the Pharmaceutical, Biotechnology and Clinical Research industry.
 

ID-Clinical Candidates Job - Program Director


Reference IDSS700103DP
Title Program Director
Description Job Summary

Provides customer-focused leadership in managing multiple Phase I through Phase IV clinical trials across functional areas. This position is accountable for the successful completion of all assigned projects, where success includes all of the following: on-time, on-budget, in compliance with all applicable regulations, quality data and reports, satisfied customer. This position is also accountable for proposal development and bid defense for assigned RFPs and functions as an integral part of the selling team. Is administratively responsible for assigned clinical staff.

Responsibilities

Manages one or more full-service, multi-national and/or domestic projects, from proposal development to final deliverables to the customer.
Coordinates project organization, implementation and management activities between all company operations and the client. Serves as the primary client contact at the project operational level.
If assigned to global projects, may serve as the Global Project Leader or Regional Project Leader for multi-national trials.
Directs the preparation and maintenance of the Project Plan (including timelines) and monitors against projected progress; ensures project activity compliance with plan. Develops and implements solutions in order to adhere to study timelines, schedules, resources, budgets, etc. for the projects for which he/she is accountable.
Assesses resource needs for multi-national and/or local trials, and in conjunction with their manager and other Brand / Support Unit managers establishes appropriate project team. Monitors ongoing resource needs for assigned projects.
Provides appropriate project tracking using computer assisted programs and ensures up-to-date tracking and resolution of any project issues.
Assures the development of Project Specific Operating Procedures (PSOPs) by functional area, as necessary.
Directs proposal preparation (including budget) and bid defense activities as required.
Evaluates and manages project budget against project milestones to ensure project profitability.
Assesses scope of work against contractual agreements and identifies change in scope; when appropriate, responsible for preparation of CIS and presentation to customer.
Prepares and presents study material at client meetings and communicates outcomes to project team.
Administratively responsible for assigned direct reports, whether or not on assigned projects.
Participates in new business development activities including participation at client presentations.
Skills & Attributes

Education: BSc/BA, RN, or equivalent; graduate degree preferred but not required.

Candidate should have clinical research project management experience; and clinical research experience or previous related health care or clinical research work experience (e.g. study coordinator). Knowledge of regulatory requirements /guidelines is mandatory.

Previous technical and managerial experience in conducting multi-national and/or local clinical trials in a hospital setting, pharmaceutical company, or CRO is preferred, but not required. Experience or education indicating a sound basic knowledge of medical and pharmaceutical terminology is required.

In addition to being qualified by education and experience as described above, the Program Director must have a record of superior performance in a similar role and must possess the knowledge and technical / management skills requisite for success as a Program Director. These include:

Excellent verbal and written communication skills, along with excellent organizational, record retention, time management, customer service, and interpersonal skills. Excellent decision making and creative problem solving skills.

Ability to direct, lead, negotiate and act as a liaison between multi-disciplinary departments. Ability to develop, organize, and manage multiple tasks. Ability to travel domestically and internationally as required. Ability to work independently. Proficient in the use of computer and software systems (e.g. Excel). Ability to understand, interpret, and explain complex medical details.
Good command of written and spoken English.

Knowledge of and a clear understanding of the overall drug development process, including experience with most phases of the clinical research process, including but not limited to:
study initiation procedures, clinical monitoring functions, drug safety and regulatory affairs issues, data flow from sites to data processing, review, resolution, analysis and report generation, regulatory requirements, and ICH Guidelines.
Salary Excellent package offered
Location Europe
Contact david.proudfoot@id-ss.com

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