The Associate Director, Study Start Up & Clinical Support Services manages the Study Start Up & Clinical Support Services staff to ensure successful execution of Study Start Up activities, including site feasibility, site identification, site activation, ongoing study support in all areas of administration, and ongoing collection and management of essential documents and Trial Master File as contracted for projects at MedSource. Conducts resource management and utilization and performance management of the Study Start Up and Clinical Support Services staff. Leads quality assurance and process improvement efforts. Analyzes processes and develops strategies to increase efficiency. Participates in business development as subject matter expert in Study Start Up & Clinical Support Services functions.
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.
- Supervise, mentor and train staff on proper procedures and processes. Conduct interviews and selection, terminations, professional development, performance appraisals, job description preparation and employee training. Advise Study Start Up & Clinical Support Services staff on administrative policies and procedures, technical issues and prioritization.
- Facilitate processes, resourcing and communications within and across departments. Assign and coordinate resourcing to accommodate ongoing workflow. Monitor productivity and quality of department functions. Act as liaison and facilitator between customers and senior management for related tasks/issues.
- Support financial management of Study Start Up & Clinical Support Services tasks on projects, as well as provide strategic development for process improvements.
- Create, review, approve and/or present prepared information at management team and/or customer meetings. Support executive management with accurate creation and implementation of Study Start Up & Clinical Support Services workflows. Identify and report on areas of process and risk assessment.
- Provide direct oversight to Study Start Up & Clinical Support Services staff and provide feedback in 1:1 meetings.
- Develop, revise and maintain SOPs and provide training on new and revised SOPs as needed. Develop and implement training programs for appropriate departmental teams.
- Oversee development, implementation and maintenance of Study Start Up & Clinical Support Services 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.
- Work closely with project team and sponsor to develop SSU Plan and processes, including timelines and milestones at the beginning of a trial. In addition, prepare any updates to the plans as needed throughout the life of the study.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- Bachelor’s Degree (BA, BS) preferred, or equivalent combination of education, training and experience.
- Extensive experience working in pharmaceutical, biotechnology or CRO industry and an in-depth knowledge of the clinical trials process are required.
- Experience working in Study Start Up and clinical records/trial master file management required.
- Experience in personnel management required.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Good computer skills including MS Word, Excel, PowerPoint, Outlook.
- Ability to work individually and as part of a project team, meet deadlines & take instruction from multiple individuals.
- Must have excellent verbal and written communication skills, as well as organizational skills.
- Excellent interpersonal and organizational skills with strong attention to detail.
- Extensive experience with and working knowledge of ICH/GCP documentation process.
- 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
- Approx.10 % of travel required
MedSource is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.