Study Start-up Lead

Who We Are

Celebrating 40 Years!

Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.

What You'll Do

We are seeking a Study Start-Up Lead (Remote/Hybrid) in the UK

The primary responsibilities of this position include, but are not limited to, the following:

• Manages start-up activities for assigned studies including supporting site feasibility, essential document preparation, supporting Investigational Product (IP) release, site initiation visits (SIVs) readiness, and overall site activation readiness to ensure deliverables meet quality and regulatory requirements, project timelines, and sponsor expectations.
• Reviewing and approving site activation package
• Ensure that all assigned start up activities are on track and support study deliverables
• Localise Site Informed Consent forms
• Maintaining accurate, complete and current information in the appropriate databases
• Organises and tracks study documents
• Collecting and reviewing, of regulatory documents for completeness and compliance to the regulations set forth by ICH GCP, local requirements and the study
• Prepares all start-up and amendment packages prior to distribution
• Filing in eTMF system and accurate Trial Master File Maintenance
• Maintains Consistent site follow-up and ensure documents required are collected in a timely manner
• Ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement
• Collaborate with Clinical Operations Team to identify innovative practices to optimize country operations and operational excellence, in terms of study start-up activities to increase performance, productivity, and business impact
• Research start up issues and provides guidance and advice to colleagues
• Guides others to strengthen their knowledge, skills, and abilities needed to accomplish tasks
• Supporting the development and maintenance of SOPs, tools, and templates for study start up activities
• Participates in various start-up and Sponsor Kick-Off meetings
• Escalate study issues appropriately and in a timely manner
• Demonstrates understanding of customers’ needs and ensures alignment
• Assists in employee development
• Supports in audit preparations
• Performs other duties as assigned

What You Need

Level of Education

• Bachelor’s degree required preferably in a life science field or equivalent
• Master’s degree preferred

Prior Experience

• Minimum of 3 years prior experience required
• Prior experience in a CRO/pharmaceutical environment preferred

Skills and Competencies

• Detailed understanding of clinical trial start-up processes.
• Excellent understanding of clinical trial process across Phases I-IV and ICH GCP.
• Self-motivated, leverage resources to complete work efficiently, using time effectively
• Takes a systematic approach to problem solving
• Highly organized ability to prioritize tasks and track assignments to meet the needs of internal and external customers
• Demonstrate openness and honesty while acting in accordance with moral, ethical, professional guidelines
• The ability to convey or share ideas in concise terms that others understand
• Correctly interprets messages, asks questions when clarification is needed
• Is adaptable and flexible to changes with a positive attitude and a willingness to learn new ways to accomplish work activities and objectives.
• Ability to adjust and reprioritize with the needs of Theradex Oncology
• Works with others to establish and maintain a positive working relationship while offering added value and insight.
• Working collaboratively with others to agree on outcomes and actions to complete tasks or achieve goals
• Demonstrated persistence in bringing issues to closure
• Views situations from multiple perspectives and potential impact outside one’s area
• Guides others to strengthen their knowledge, skills, and abilities needed to accomplish tasks
• Uses appropriate interpersonal style to gain acceptance of ideas and plans

Additional Requirements

• Proficient knowledge of MS Office, in particular Excel.
• Experience with Veeva Vault (Desirable)
• Detail oriented
• Knowledge of eTMF preferred
• Excellent verbal and written communication skills
• Fluent knowledge of written and verbal English

What we offer:

We offer a friendly and supportive culture that puts people first. We provide a competitive compensation and benefits package including 6% pension contribution, private medical insurance, sick pay and income protection insurance, life assurance and eyecare voucher scheme.

This job does not offer company sponsorship 

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.