Study Start Up Lead

General Description:_
- Demonstrates a high level of clinical operations knowledge, organizational, communication skills, project management and leadership competencies. Experience in the study start-up phase within clinical operations is preferred, but not essential.
- Implements best practices and shares lessons learned with team and other colleagues, as appropriate
- Drives, manages and leads all aspects of clinical start up activities in a region or country on a study. Delegates and oversees clinical operations tasks to other clinical operations representatives in the team, as appropriate. May oversee more than one study and/or multiple countries within the region.
- Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs
- Escalation point person to next level of study oversight/governance as necessary

Essential Functions of the job:

- Independently or under supervision (for Associate level SSUL), lead country Study Start Up teams to the delivery of clinical start-up component of assigned studies with accountability for time and quality for assigned activities, which include, but not limited to:

- Investigator/Site identification, including conduct of feasibility activity to identify investigators and conduct site visit to confirm qualification for the required study;
- Activities related to preparation, coordination and submission to CEC/LEC; obtain approval for countries in region. Perform independent quality review of submission packages;
- Responsible for the translation and coordination of translations for documents required for submission;
Responsible for the timely follow-up for queries made by CEC/LEC;
- Collaborates with Regulatory Affairs team, for co-ordination of timely MOH/CEC/LEC submissions; ensuring all are performed in line with planned site activation timelines.
- Provision of country-specific study start-up expertise to study team;
- Create study start-up document templates, as required;
- Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS.
- Perform timely and accurate review of, maintains oversight of study start-up documents in the eTMF.
- Work closely with regional COM/ACOM to plan and execute timelines and strategy related to the Start Up phase of the clinical study. Attends and has input to regional CST meetings, including regional Kick Off Meeting.
- Work closely with CBO to ensure dispatch, negotiation, execution and tracking of contracts with sites adheres to the agreed and planned timelines.
- Assist in company Study Start Up SOPs development.
- Establish, maintain and enhance relationship with key opinion investigators and sites.
- Proactively identify potential issues and seek improvement. Take initiative for issue resolution within and outside Study Start Up team. Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans.
- Provide ongoing mentoring and training to Study Start Up Specialist(s) and other Study Start Up Lead(s).
- Perform other duties as assigned by Monitoring Excellence Management Team.

Supervisory Responsibilities:

- None

Education Required:

- Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline* with minimum of 3-5 years of experience in clinical operations (Manager).
- Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline* (eg Registered Nurse) with minimum of 1-3 years of experience in clinical operations (Associate Manager).

Computer Skills: Good to advanced knowledge of Microsoft Word, Excel, PowerPoint, SharePoint, and Outlook. Demonstrates good working knowledge of Clinical Trial Management Systems.

Other Qualifications:

- Fluent in written and verbal English
- Strong interpersonal skills, can do attitude and problem-solving skills
- Able to multi-task and meet compressed timelines

Travel: Limited to no travel expected

Location: Basel, Switzerland or remote location in Europe

Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and asks for clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others