As an innovative Research Institute, Alcedis provides clinical research with a modern information technology architecture. Flat hierarchies and a decision-friendly culture create a flexible and dynamic environment.We are looking for a Clinical Project Manager / Clinical Trial Coordinator (region: New Orleans) to support our clinical operations department in the management of clinical studies carried out at Tulane University.You will be responsible for clinical study activities at Tulane University and will be in regular contact with the local team at Tulane University as well as the clinical operations team at Alcedis, Germany.
Responsibilities
- You are responsible for project planning and project implementation including study start-up activities, ongoing study management as well as coordination at every stage of the clinical trial journey
- Monitoring of the Project Plan in terms of time schedule and correct implementation
- Project budget responsibility and project budget controlling, reporting to the functional unit head
- Creation of study documents and preparation of trials (site contract management, creation of print materials, organization of trial material, organization of trial meetings, etc.)
- Supervision and coordination of the trial sites (communication, training, shipping and tracking of trial documents, payment, etc.)
- Creation and management of the Trial Master File
- Coordination of tasks for the functional units Data Management, Pharmacovigilance, Biometrics, IT, Contract Management, Business Development and Medical Writing
- Management of regulatory notification and approval procedures, submission of applications according to national requirements
- Coordination of monitoring activities, review of monitoring reports
- Supervision and coordination of subcontractor activities
- Coordination of the project team across the various functional units and national borders (USA-Germany)
From day one in this role, we’ll expect you to have
- Successfully completed a degree in Natural Sciences or a comparable suitable qualification, ideally with a medical focus or have a study nurse or comparable qualification
- Professional experience within the industry, e.g. CRO, pharma or biotech (gt;5 years of experience in clinical research/monitoring or project management is desirable)
- Experience with submission to IRB / ethics committee and in data privacy and protection
- Good knowledge of GCP/ICH
- An analytical, solution-orientated and responsible approach
- Experience working with electronic data and databases and have good knowledge of Office applications
- A high level of social competence and a strong ability to work in a team are a matter of course for you
- You work independently and with foresight in planning and implementation
- Very good communication and organizational skills
- Excellent English language skills (spoken and written)
What we can offer you
- Health, dental and vision insurance for you and your dependents
- Employee life insurance
- Health Savings Account (HSA)
- 401(K)
- Generous share options - every employee is an owner
- 15 paid vacation days
- Generous parental leave policy
- Family first culture - giving the flexibility you need
- Growth amp; development opportunities
Come join us!
We believe magic happens when you bring together diverse ideas, experiences, and styles. We want to create a world where people live longer, fuller lives, and to do that well we need a team that represents all of the people and communities who use our solutions. We aspire to create an environment where everyone has the opportunity to do their best work. We are always looking for ways to improve so if you have any suggestions, please get in touch.
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