Clinical Project Manager
: Job Details :

Clinical Project Scientist (Study Responsible Scientist)

6-12 month contract with extension

$100-115 an hour

Services Overview:

The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials.

Key Responsibilities and Deliverables:

· Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study

· Develops clinical research protocols, study case report forms, informed consent

· Develops the medical review plan to support the statistical analysis plan

· Plays a key role in the medical review of the study data and assists in coding, analysis and documentation

· Validates and interprets results of phase 3, 3b, and 4 investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals

· Ensures team member adherence to clinical research guidelines and safety procedures

· Communicates detailed outcomes and results of research findings to relevant partners

· Provides input in managing project budgets and projections

· Serves as liaison to global clinical sites for medical questions related to the clinical research trial

· Presents study status at internal/external meetings, including investigator meetings and governance committees

· Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities

· Participates in/leads interactions with health authorities

· Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies

· Reviews and maintains correct standard operations, procedures, and protocol

Qualifications:

· A minimum of a bachelor's degree is required; and advanced degree is preferred.

· A minimum of 3 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required.

· Experience in immunology therapeutic area is preferred.

· Significant experience with clinical trials including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.

· Excellent written communication, oral communication, and presentation skills are required.