Clinical Research Lead

• For our customer located in Basel/Switzerland we are currently looking for a
• : Clinical Research Lead (m/f/x)

General Information

• Location: CH-Basel (4 days onsite, 1 day remote per week possible)
• Branch: Pharma

• Duration

• Gross Rate Range (given by client) 71-89,50 chf/h gross, typical monthly salary e. g. 80chf*160h=12.800 chf gross
• Tasks & Responsibilities
• Lead the clinical protocol development process in collaboration with the Medical Lead and other line functions; responsible author for clinical protocols, amendments, etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which resides in other line functions; contribute to the development of clinical sections of study-level regulatory documents.
• Lead development of strategic and scientific input into study concept, feasibility, and ability to execute; develops and implements study-level operational execution plan in partnership with key cross functional partners, if applicable.
• Collaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met.
• Lead a global cross functional CTT to ensure all trial deliverables are met; sets stretch goals, promotes realistic planning and timelines, and presents actionable alternatives to accelerate timelines.
• Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations.
• Lead the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions, and partners on data analysis and data interpretation, including safety trend analysis, signal detection, development of first interpretable results, reporting clinical study results in CSR, and internal/external publications.
• Prepare and lead dose escalation meetings with investigators.

Coordinate the real time availability of quality clinical trial data, to provide consolidated information for dose escalation meetings and Phase II data reviews with relevant stakeholders.

• Proactively lead risk mitigation discussions, risk management and implementation at the trial level.
• Responsible and accountable for forecasting and managing overall study budget(s) in collaboration with key partners.
• Collaborate with key partners to set vendor strategy and timelines for assigned studies.
• Responsible for implementation of best practices and standards for trial management, including sharing lessons learned.
• Must Haves
• Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (Ph D/MD/ Pharm D/ Masters).
• Approximately 6+ years’ experience in clinical trials development.
• For TCO: Strong understanding of oncology/haematology and demonstrates high learning agility.
• For TM: Demonstrates high learning agility in therapeutic area.
• Demonstrated ability to confidently drive complex collaborations through unpredictable circumstances and higher paced changes.
• Demonstrates leadership and influence by creating a positive work environment by inspiring and encouraging mutual respect, instills innovation and accountability on a functional and trial level.
• Demonstrates strong interpersonal skills with a proven track record of building strong positive relationships.
• Demonstrates strong tolerance for ambiguity, willingness to adapt, and willingness to speak-up and challenge.
• Embraces a culture of diversity, inclusion, quality, innovation and always driving forward with integrity.
• Proficient in clinical trial methodology with a strong emphasis in early clinical development.

Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills.

• Track record of successfully managing or leading multiple complex clinical trials concurrently. Used to managing multiple priorities.
• Demonstrated capability to interpret, discussion and represent trial level data.
• Working knowledge of clinical finance principles to manage efficient expenditure to minimize variance between actual and forecasted spend.
• Maintain extensive knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of SOPs and internal policies.
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