IDDI (International Drug Development Institute), founded in 1991, is a highly recognized biostatistical and eClinical service provider in the field of clinical research. To support our growth, we are actively looking for a:
You will be joining an international and multi-cultural company that includes over 20 different nationalities with English as our working language. Our employees are our strongest asset. Our customers value our flexibility, responsiveness and proactive approach.
By joining a group of 15 highly skilled specialists in the Project & Document Management team, the successful candidate will strengthen the experienced group in Raleigh, NC – US.
As Project Manager you will be the key client contact for projects where IDDI is performing multiple tasks (randomization & trial supply management (RTSM), clinical data management, client support and system validation, biostatistics, and/or medical writing).
Your responsibilities will be to:
- Oversee the IDDI project team providing RTSM, clinical data management and/or statistical analyses for clinical trials.
- Ensure optimal relationship with clients through day-to-day communication, project meetings, reporting, and quality assurance.
- Ensure a positive relationship between different IDDI departments to ensure optimal data processing and efficient communication.
- Ensure that appropriate documentation is filed in the Trial Master file and that the services are produced and maintained for each project.
- Create and maintain the project planning and ensure that milestones and Team Lists are up to date and communicate to team in case of modifications.
- Assist Quality Assurance to prepare customer audits of their projects and attend the audit as necessary.
- Detect, resolve and/or escalate project problems and conflicts.
- Review contract and budget amendments.
- Perform regular project budget analysis in order to ensure that the project is on time and in budget.
- Ensure that team members assigned to the project receive the appropriate project specific training.
- Develop and update SOPs/WINs/Guidance documents with respect to Project Management processes.
The successful candidate must have a master’s degree in science, biostatistics or a health-related field and at least 5 years of experience in clinical trials. In addition, the position requires:
- Good knowledge of IDDI’s areas of expertise (RTSM, Clinical Data Management and Biostatistics).
- Experience in Project Management in Clinical Research managing multidisciplinary project teams, planning and budgets.
- Experience of at least 2 years in either Clinical Data Management or Biostatistics.
- Thorough knowledge and understanding of CROs and the pharmaceutical industry.
- Knowledge of Microsoft tools: MS Project, Excel, Word, PowerPoint
- Excellent oral and written English and good communication skills.
- Excellent level of leadership, self-motivation, business acumen and negotiation.
- Good problem-solving and interpersonal skills (communication, organizational and time management skills).
- Commitment to quality.
- Strong independent worker and team player.
- Ability to travel internationally to meet with clients, prospects and attend face-to-face meetings (4-5 times/year).
A unique opportunity to work in a friendly, team-oriented and stimulating environment. We regularly enjoy company-wide events such as BBQs, family-day outings, sports, and charity fundraisers, giving the chance to share time together. With a low employee turnover rate, we offer job stability and growth opportunities through on-the-job training and mentoring programs. Working at IDDI will bring you an expertise that is widely recognized in our industry. We offer a competitive salary and benefits package including health, dental and vision insurance plans, short and long term disability insurance, life insurance as well as flexibility for a better work-life balance (working hours, home-working opportunities, paid time off).
Interested in this challenging position?
Please send your CV and cover letter highlighting your motivation and relevant professional experience for the position by e-mail at firstname.lastname@example.org (to the attention of Ms. Tamara Judge).