| Job Description | Responsible for the planning, development, implementation and ongoing management of all of the operational aspects of clinical trials including protocol development, defining scope of work, resource planning and allocation, recruitment of clinical investigators, training, planning and execution of investigator meetings, establishment and adherence to timelines, ensuring compliance with protocols and clinical/corporate objectives, adherence to regulations and company Standard Operating Procedures (SOPs), and clinical supply management. Supervise staff as deemed appropriate by manager. Provides leadership, coaching, mentoring and training to study team members as well as liaison with cross-functional department personnel. Maintains and applies a thorough understanding of GCP/ICH regulations. Demonstrates ability to function independently and cooperatively and exercises judgment in developing methods, techniques and evaluation criteria for obtaining solutions and resolving problems. Utilizes in-depth knowledge of clinical research functions in cross-functional teams to develop consistent procedures/methods. Encourages collaboration across project teams and provides input, guidance and feedback to guide the process.
Essential Job Responsibilities:
Defines scope of work within projects, resource needs and allocation.
Participates in determining outsourcing strategy and vendor selection, working closely with Clinical Operations management to establish timelines and budgets.
Facilitates and troubleshoots program issues.
Tracks and maintains program progress and ensures adherence to project budget and timeline.
Development, coordination and tracking of program training; and, oversee and/or participate in, training and mentoring junior project support staff and ancillary staff as needed.
Work with project team to track, review and report performance of CRO and/or other third party vendors against contract, expectations and project timelines.
Oversee development and maintenance of internal databases and project plans.
Design and coordinate the development process for procedures and document management tools. Designs and implements additional databases to improve tracking and efficiency of operations including study specific documents and forms.
Monitor and coordinate efforts of cross-functional project teams.
Serve as primary project contact with CRO to ensure communication integrity.
Develop and initiate feasibility studies and patient recruitment strategies.
Oversee the management of the operational aspects of clinical trials including protocol development, investigator recruitment, patient enrollment, study specific guidelines and processes and quality of data collection.
Foster positive working relationships with key investigators, opinion leaders, site personnel and collaborators.
Coordinate preparation of clinical document team in support of regulatory submissions as well as review of documents such as Investigator Brochures, clinical study reports and annual reports.
Designs, implements, enforces and maintains improved processes, databases and operational management within the Clinical Operations Department.
Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents.
Prepare and present project information at internal and external meetings to represent the program(s), including scientific meetings as deemed appropriate by Clinical Operations Management.
Provide project/team training as required to ensure all team/site members are trained on study procedures and execution.
Maintains knowledge of relevant regulations and guidelines and ensures compliance with GCP standards, applicable regulations, Standard Operating Procedures (SOPs) and study specific documents, processes, policies and procedures and meets quality and timeline metrics. Coordinates and ensures consistency of study specific templates/guidelines.
Perform periodic evaluation of the performance of direct reports.
Partner with other Project managers to develop and implement process improvements.
Additional responsibilities may include:
Responsible for assisting with recruiting, hiring, mentoring and managing Clinical Trial Managers, Clinical Research Associates, and Clinical Operations Personnel.
Input and maintain study specific data in CTMS
Qualifications/Experience:
Masters degree preferred. Bachelor’s degree (BA, BS or BSN) from a four-year college or university in a scientific discipline or equivalent combination of education and work experience. Minimum of eight years related experience and/or training, two of which include leading global clinical trials or global project management. Knowledge of GCP/FDA/ICH regulations required. Strong medical/science background with oncology, nursing or health care related experience required. CRO experience is advantageous.
Work Environment:
This is a Portland, Oregon-based position. The work is performed in a typical office or home office environment. Solid computer skills are essential. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. Ability to travel via. Air carrier is required often.
Personal Skills and Attributes:
Strong communication skills, both written and oral
Solid problem solving skills
Business objections focused
Proven ability to effectively lead teams
Strong team player
IT literate |
| | Company | | Galena Biopharma | Job Code | | State or Province | | Oregon | | |
|
