Consultant Clinical Operations

vor 3 Monaten

Basel, Schweiz SwisSolution Human Capital AG Vollzeit

Are you interested in a 30% role as a consultant for the Clinical Operations team? Then keep reading

Tasks

Project Initiation & Planning
- Manage study start-up activities
- Provide input to project tools, PL project plan, Central File Maintenance Plan
- Provide input to the format and content for sponsor reports
- Provide input to and oversight of site selection strategy plan
- Develop site selection and monitoring plans for the team
- Review and provide input into patient recruitment plan and retention plan
- Establish efficient/effective working relationships with other functional Leaders and coordinators across geographies within a given program
- Develop study plans, tools and forms
- Maintains oversight of the study budget
- Provides input into study planning and budget forecasting

Project Implementation, Control & Evaluation
- Provide leadership and direction to project team members
- Evaluate and identify resourcing needs and continuously monitor the use of resources over the project life cycle of the project
- Provide productivity targets to the team and project
- Early recognize areas of potential problems and provide input to contingency plans
- Monitor study timelines, patient recruitment, retention and data cleaning to ensure the successful outcome of the project
- Maintain and assure the quality of work generated and escalate and follow up as appropriate
- Implement and instigate process improvements within the project
- Provide input to the Revenue Recognition forecast
- Identify changes in scope and liaise with Project Leader
- May be required to conduct site visits as per client or project demands
- Participate in client, investigator and team meetings
- Prepare, participate in and follow up on audits/inspections

Project Close-out
- Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activities
- Together with Project Leader ensure all administrative closeout procedures are completed, according to Project Close-out Checklist
- Together with Project Leader ensure the project is archived and all documentation returned to the client as specified by the contract
- Participate in end-of-study meeting and give input to lessons learned information and feedback relevant information into the relevant functions

**Requirements**:

- Master degree or equivalent university education/degree in life science or healthcare
- 5+ years’ experience in clinical trial management (incl. early trials) is required, ideally in a biotech setup
- Proven experience in Phase 1-2 in immune-oncology solid tumours is essential
- Substantial experience in clinical research including relevant experience as a Team Leader in Clinical functions or proven experience in coordinating clinical trials.
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study-specific procedure
- Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims)
- Strong understanding of the cross-functional activities
- Leadership skills
- Strong customer focus
- Effective time management in order to meet daily metrics or team objectives
- Ability to travel when required
- Excellent written and interpersonal skills, ability to interface and communicate effectively with management and other functions within the organization
- Fluent in spoken and written English, additional languages are an asset
- Strong leadership skills with collaborative attitude, Team player
- Excellent planning and strong organizational skills, able to manage multiple tasks simultaneously and set priorities
- Excellent conceptual science thinking, which is used to approach and solve complex issues and their implications
- Self-motivation and able to work independently in a fast-pace, small company environment
- Pro-active and problem-solving attitude
- Willing to work hands-on in a very small team with limited internal resources
- Personal resilience, perseverance, energy and drive

**Benefits**:

- 5 Weeks vacation
- Career Opportunities
- Part time possible
- Social events in the team

Our client is a biotech company focused on improving significantly the survival of cancer patients. The goal is to improve survival rates by developing novel targeted anticancer therapeutics which provide a multi-pronged approach against solid tumours.

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