Location: United States - home or office based
Schedule: Full-time, permanent
CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Clinical Research Department Director. You will be responsible for the accountability and oversight of a range of clinical projects, ensuring they are delivered on time, within budget and to the required quality standards. Your projects will be from our varied client base, ranging from small to mid-sized pharma, biotech and medical device companies.
Main Job Tasks and Responsibilities:
- Develop and implement the strategy for the assigned projects in collaboration with the Global Head of Clinical Research Division.
- Manage the projects at a global level and ensure consistent and continuous focus to Client's specifications and satisfaction.
- Meet and exceed the project's deliverables, including timelines, budget and quality
- Set project plans, monitors the adherence to the plans. In addition, proactively address with the Project Leader/Project Director and the team regarding any risk of variations.
- Plan and manage the Project Boards for assigned projects and agrees to the project needs.
- Identify, resolve and escalate any issues that arise as required.
- Achieve the Project KPIs, understanding performance issues, and shares best practices with the team
- Define, plan and manage internal and external communication on the assigned projects planning and status.
- Serve as a source of scientific and therapeutic expertise.
- Give scientific and operational input to proposal development and contributes to the preparation of the strategic documents and bid defense meetings.
- May act as Program Director for existing and potential new projects.
- May participate in Monitor's and Investigator's Meetings.
- Monitor and enforces compliance with CROMSOURCE systems, processes, policies and all applicable regulations.
- Participates in the review and design of processes and SOPs.
- Maintains relationships with the Sponsor.
- Member of the Steering Committee.
- Leads by example by living and enforcing CROMSOURCE's values.
Education and Experience:
- University Degree in scientific and/or medical disciplines.
- At least ten years of experience within Clinical Research in the CRO/Pharmaceutical industry, in a Project Management function.
- Demonstrates an excellent knowledge in developing work organizational models.
Specific Role Requirements and Skills:
- Strong knowledge of clinical trial operations, ICH-GCP guidelines and other applicable regulatory requirements.
- Excellent interpersonal and communication skills (both written and verbal).
- Proven leadership skills.
- Ability to adapt and motivate teams, both individually and collectively.
- Excellent problem-solving capabilities through early identification.
- Flexible approach.
- Demonstrates a strong understanding of fiscal, finance and budgeting issues.
- Fluent in English.
- Proficient in Microsoft Office (including Word, Excel and Outlook).
- Willingness to travel.
- Full health insurance benefits that include health, dental and vision
- 401K Plan with 5% company match after satisfying 90 days of employment
- Short term and long-term disability insurance
- Life insurance
- Paid vacation, sick leave and holidays
- Excellent work-life balance
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Key words: Clinical Research Department Director, Clinical Research Director, Study Director, Project Director, Clinical Operations Director, Contract Research Organization, CRO
Clinical Operations Director