As a Clinical Research Manager you will work within Clinical Pharmacology and Pharmacometrics. You will be responsible for the Clinical Trial Management and Oversight for the activities of outsourced Phase I trials.
These services lead Study Team meetings related to clin pharm outsourcing activities and ensures deliverables progress according to agreed upon timelines and milestones.
This service supports the Clinical Pharmacology and Pharmacometrics (CPP) Business Support Group. Interface with stakeholders;
internal and external to CPP such as Clin Pharm Leader, Clin Pharm Scientist, Pharmacometrics leader, Global Trial Manager, Study Responsible Physician, Global Data Manager and vendor staff.
Takes ownership for assigned responsibilities. Demonstrated competency to act as a backup or first point of contact in absence of CPP Project Lead colleagues.
Advanced is given assignments that are more complex and / or have a greater potential impact on business results. May contribute to process improvement and / or non-project work.
What are your responsibilities?
Lead the Phase I Study Team meetings including providing updates to key team members on Clin Pharm deliverables (i.e. Synopses, Protocols, Pharmacokinetic / Pharmacodynamic parameter generation, reporting) status.
Assist with report preparation related to departmental resources, assignment and tracking of CPP deliverables.
Manage timely and accurate documentation and communication of trial progress.
Act as primary clin pharm outsourcing contact for assigned studies.
Partner with the Clin Pharm Leader, Clin Pharm Scientist and / or Pharmacometrics Leader for outlining expectations and timelines for each study with outsourcing needs.
Assist with creation of timelines, reviewer lists, organization of meetings and interact closely with cross-functional team to ensure appropriate content is available on time and with quality for trials and regulatory submissions.
BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
4 years clinical trial management experience in the pharmaceutical industry or CRO.
Strong working knowledge of ICH-GCP, local laws and regulations.
Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of Phase 1 trials.
Experience and ability in coordinating global or regional teams and meetings in a virtual environment. Proven ability to foster team productivity and cohesiveness.
Understanding of scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical R&D process is required.
Strong IT skills, including knowledge of standard Microsoft applications, and willingness to learn new systems.
Effective leadership skills and ability to manage multiple stakeholders.
Strong project planning / management.
Independent complex decision making.
Solution oriented and proactive risk identification and mitigation.
As an ambassador you have the opportunity to grow within international companies where you can build a strong network . Through a personal follow-up , you receive quality support in every step that you accommodate.
Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.