Provide feasibility and site identification activities in support of assigned projects to facilitate efficient and expeditious study start-up; including performing relevant and quality research, data and analysis, site outreach and recommendations. Provide leadership to junior department and project team members. Develop and implement training and process improvements.
DUTIES AND RESPONSIBILITIES:
- Work closely with functional team management to ensure deliverables in accordance with ICH-GCP, relevant Standard Operating Procedures (SOPs) and/or Sponsor-specific requirements.
- Contribute or advise on study strategy for the Request for Proposal (RFP) and bid defense process with regards to recommendations of countries, site numbers and timelines as well as identify key areas that may require further considerations, e.g. regulatory, clinical, and liaise with relevant operational heads.
- Review protocol and client support documents to ensure good understanding of the requirements for study delivery.
- Perform detailed data analysis, including review of public domain information and country and site level feedback, in order to support the Company’s strategic positioning of a clinical trial. Present prepared information at proposal, project or departmental review meetings.
- Use data from multiple sources and databases to provide recommendations on key investigators for site-level feasibility investigator lists. Provide a list of recommended sites for site qualification visits based on feasibility results.
- Working independently, prepare client-ready deliverables, including development of feasibility results into the form of a report to be integrated into the proposal or to be provided to the client as a stand-alone piece of work. It is expected that the Feasibility Lead will oversee and conduct all stand-alone feasibility projects and will produce detailed feasibility reports and findings.
- Coordinate and oversee the site identification process including engagement with investigators or site staff, and collation and tracking of results. Work closely with project team and sponsor to develop Site ID Plan at the beginning of a trial. In addition, prepare any updates to the plans as needed throughout the life of the study. Establish and maintain relationships with key investigators, collect information to define the ideal site for a study, perform the identification of suitable sites for a study, and contribute to efforts for site identification.
- Work closely with project teams to ensure efficient feasibility and site identification processes for assigned projects in accordance with ICH-GCP, relevant Standard Operating Procedures (SOPs) and/or Sponsor-specific requirements.
- Perform administrative and analytical responsibilities to support the successful completion of feasibility and site identification deliverables.
- Act as a primary contact for the investigational sites and project teams to collect data for feasibility and site identification.
- Assist in collection, QC and tracking of site-specific Confidential Disclosure Agreements.
- Oversee development, implementation and maintenance of site identification systems; acting as systems administrator and/or supervise a systems administrator. Develop requirements for modifications to existing systems and reports; provide input on requirements for long-term plans.
- Prepare, proofread, and edit correspondence and other written materials (presentation, reports, etc.) as needed.
- Attend project team meetings and training sessions according to project and/or Sponsor requirements.
- Monitor number of hours/tasks available for site identification activities per project specifications; escalate discrepancies in a timely manner.
- Supervise, mentor and train department staff and new-hires. Assist in development, revision and maintenance of SOPs and provide training on new and revised SOPs as needed. Develop and implement trainings and process improvements.
- Conduct interviews for potential candidates for employment and provide feedback to recruiting.
- Liaise between business units to maintain and foster good working relationships and communication between departments to facilitate continuous growth and development.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- Bachelor’s degree (BA/BS) preferred or equivalent combination of education, training and experience.
- Experience working the pharmaceutical, biotechnology or CRO industry and knowledge of clinical trials process required.
- Experience in feasibility analysis and site identification required.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Excellent oral and written communication skills.
- Excellent interpersonal and organizational skills with strong attention to detail.
- Good customer/client relationship management and proactive problem-solving skills.
- Knowledge of the principles, methods, and procedures of clinical research.
- Good computer skills including MS Word, Excel, PowerPoint, Outlook.
- Experience with ICH/GCP documentation and process preferred.
- Ability to assess, coordinate, and organize/reorganize workload of
multiple projects in accordance with project priorities/assignments and timelines with focus on execution.
CONDITIONS OF EMPLOYMENT:
Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Work is normally performed in a typical interior/office work environment
MedSource is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.