Job Title: Clinical Outsourcing Associate I
Duties: The Clinical Outsourcing Associate is a contract position within Clinical Operations organization, reporting to Sr. Manager, Clinical Outsourcing. The Associate is accountable for the coordination of key activities such as contract management, participating in vendor selection, and overall conduct of Clinical Outsourcing activities across the Development organization.
This position will be a good fit for a self-motivated individual who is detail orientated, adept at multi-tasking and is a team player.
Skills:
Contract, budget and procurement process management in support of Development organization. This includes:
Drive contract & budget document coordination from submission to full execution.
Lead submission and follow-up of Development contract requests via procurement operations system (Zycus).
Managing traffic of in-process contractual documents to ensure timely and compliant execution.
Signature coordination, where applicable
Develop and maintain positive working relationships, transparent communications and process alignment through close collaboration with business process partners such as Legal, Finance and Quality Assurance;.
Drive Clinical Outsourcing initiative for tracking departmental activities and filing documents.
Support Development staff in tracking, completion and filing of contract Change Notification Forms (CNFs).
Coordinate the completion of Quality Assurance required documentation such as vendor selection forms, vendor qualification forms, etc.
Ensure contractual, budgetary and procurement related information is regularly disseminated to appropriate parties.
Contribute to continued process improvement efforts, including but not limited to department processes to ensure adherence to standards and efficient operations.
Gather and report data to support departmental KPIs and metrics intended to measure departmental processes and output.
Adhere to working practices and Standard Operating Procedures (SOPs).
Drive ad-hoc business projects as necessary.
Keywords:
Education:
Bachelor's degree (preferred) or equivalent experience.
At least 2 years of professional experience, preferably in biotechnology or life sciences companies with a working knowledge of drug development and the conduct of clinical trials.
Experience using Zycus (iSupplier, iContract) is a plus.
Ability to work effectively and independently in a team environment, .
Excellent organizational skills and attention to detail.
Strong analytical and business communication skills.
Skills and Experience:
Required Skills:
PROCESS MANAGEMENT
BIOTECHNOLOGY
CONTRACT MANAGEMENT
DOCUMENTATION
ORGANIZATIONAL SKILLS
Additional Skills:
BUDGET
CLINICAL TRIALS
EXCELLENT ORGANIZATIONAL SKILLS
LIFE SCIENCES
METRICS
OPERATIONS
QUALITY ASSURANCE
SOPS
CLINICAL OPERATIONS
DETAIL ORIENTATED
FILING
FINANCE
PROCESS IMPROVEMENT
PROCUREMENT
TEAM PLAYER
VENDOR SELECTION