Study Team Lead Job

STUDY TEAM LEAD needed for a long term CONTRACT opportunity with Yoh's client located in WILMINGTON, DE.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- University degree, preferred in biological science or healthcare-related field
- Minimum of 5 years experience in Clinical Operations or other related fields (Medical affairs led studies or Academic led studies)
- Extensive knowledge of clinical and pharmaceutical drug development process at various phases of development
- Proven project management delivery and demonstrated ability to manage multiple deliverables

WHAT YOU'LL BE DOING:

- Ensures External Service Provider(s) manage their portfolio of deliverables according to agreed timelines, budget and quality
- Forecast day to day management of study timelines, budget, materials and development of detailed study level plans in collaboration with External Service Provider(s)
- Track and manage to agreed study timelines, budget and ensure update of appropriate systems (eg, IMPACT) in collaboration with External Service Provider(s)
- Monitors the progress of clinical activity and produces regular and ad hoc reports and presentations to US Medical Affairs management as required
- Oversees management of External Service Provider(s) activities and other External Partners to ensure quality is consistent with company requirements
- Manages contract compliance, vendor/bid selection, cost/benefit tracking for External Service Provider(s)
- Responsible for establishing and maintaining External Service Provider(s) relationships, providing performance management as necessary
- Plan and lead activities associated with audits in liaison with CQA; contribute to regulatory inspection strategy teams as required
- Participates in negotiations and selection process of External Service Provider(s)
- Ensures operational and strategic input from other functional areas (eg. Regulatory, Patient Safety, etc.)
- Ensure appropriate training is achieved at Investigator Meeting
- Work with other members of organization and External Service Provider(s) to share knowledge, experiences and best practices
- Lead and/or provide input into non project work, training activities and development of procedures as needed
- Act as support for External Service Provider(s) for GCP and relevant processes as necessary
- Provide operational feasibility expertise and delivery of approved protocol in line with US Medical Affairs agreed strategy
- Liaise with External Service Provider(s) to identify and resolve operational issues, and facilitate start up activities

WHAT YOU NEED TO BRING TO THE TABLE:

- Demonstrate operational expertise in risk management and contingency planning
- Demonstrates an extensive knowledge of clinical study and drug development process, GCP/ICH guidelines and SOPs
- Demonstrates conceptual, analytical and strategic thinking
- Effective problem and conflict resolution skills and proven team focus
- Demonstrates good team skills including cooperation, concern for impact, willingness to learn from others, and sharing of relevant information
- Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills
- Proven leadership experience and strong collaborative communications with External Service Provider(s)
- Project management experience (specifically leading) within the context of clinical development (including scope, budget, timeline)
- Excellent verbal and written communication skills

WHAT'S IN IT FOR YOU?

Work for a multinational pharmaceutical and biologics company having a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Stephanie Tulloch

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2J2WNECLIN

Ref: AZNJP

SFSF: LS