Global Studies Leader/Project Manager (480376) (closed)
- Builds and maintains effective high performing teams with clear roles, responsibilities and accountabilities for members.
- Chairs team meetings.
- Ensures study team receives study specific and therapeutic training.
- Creates and manages study timelines, budget, resource, risk and quality plans
- Drives setting of study team goals and milestones and monitors progress.
- Establishes and maintains accurate study level timeline and resourcing plans and works with Functional Management to have correct resources in place.
- Leads development of protocol level feasibility and finalises country selection with OPL input.
- Ensures all relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent form, CRF and SSPM (study specific procedures manual).
- Ensures CTMS is updated and accurate.
- Ensures clinical data is reviewed in accordance with study Data Quality plans.
- Oversees the safety reporting activities and ensures reporting timelines are met.
- Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
- Leads the identification and selection of vendors and ensures cross functional input into the scope of work.
- Inputs into the contract and budget negotiation led by Business Manager.
The Global Studies Leader is accountable for performance, issues and their resolution to ensure studies are delivered in line with the agreed scope of work. He/she identifies and contributes to areas of best practice and process improvements. This includes:
- Cross study review of quality, productivity and efficiency.
- Incorporates learnings and recommendations from study debriefs and best practices.
- Contributes to functional excellence activities.
- Leads study debriefs (as appropriate).
- Provides study specific mentoring to GSMs and GSAs
- Ensures study adherence to ICH/GCP and SOPs
- As part of a clearly defined development plan, can take responsibility for additional activities in support of project level planning and implementation (in agreement with OPL and GSL's FM). The OPL retains overall accountability for the project.
In order to be successful within this role, qualified candidates must have strong leadership and motivational skills developed through leading successful global multi functional matrix study teams through all stages of clinical studies as well as demonstrated consistent achievement of team delivery against commitments and goals.
Qualified candidates should have a Bachelors degree in Life Sciences or Nursing equivalent with at least 3 years of solid project management experience in the pharmaceutical or biotech industry.
If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted.
Kelly Scientific Resources has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com.