Ensures the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.

Participates in the review of clinical data for analysis.

Ensures that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).

Serves as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.

Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational devices. Monitors adherence to project contract and budget.

Coordinates with clinical, business development, and operations management to identify goals and scope of clinical study projects. Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.

Supports the management and oversight of clinical study related vendors.

Reviews site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements.

Enhances department and organization reputation by participating in departmental or corporate initiatives.

Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.

Attends off-site meetings and conferences, as needed.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

EDUCATION and/or EXPERIENCE

Bachelor’s degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical research at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.

CRO experience is highly desirable.

Experience managing external vendors preferred.

Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies preferred.

Experience writing, reviewing and editing protocols and clinical study reports as well as working knowledge of the FDA submission process preferred.

SKILLS and/or ABILITIES

Ability to facilitate a teamwork philosophy with a positive attitude.

Organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives for the team.

Experience overseeing and coordinating the work of others.

Ability to work effectively and efficiently handling multiple tasks simultaneously.

Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.

Ability to manage multiple deadlines.

Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.

Strong computer skills, including Microsoft Office.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee regularly reaches with hands and arms. The employee periodically is required to lift and/or carry up to 10 pounds. Occasionally, employee stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Work in a home environment where the noise level is usually largely controlled by the employee, and a travel environment where the noise level is usually moderate to high. Employee is subject to many interruptions; pressure due to deadline requirements; and handling multiple tasks simultaneously while performing assigned duties.

SAFETY REQUIREMENTS

Originally posted on Himalayas