Clinical Trial Operations Manager
The Clinical Trial and Operations Manager (CTOM) is responsible for the day-to-day management of the clinical operations team in the USA. The CTOM is also responsible for the management of individual clinical trial(s) or clinical trial activities including set-up, execution, reporting and archiving.
The role is located in Cambridge, Massachusetts. CTOMs are encouraged to have a minimum of seven years of experience in clinical research in the pharmaceutical industry.
- Manage the US Clinical Operations Team including hiring, developing, objective setting, performance appraisal and day-to-day line management
- Mentor, coach and provide advice to clinical staff
- Supervise US clinical operations activities to ensure smooth planning, execution, monitoring as well as timely and quality completion of all studies
- Manage and coordinate clinical trial activities with clinical service providers (clinical operations, data management, central laboratory etc.) and clinical sites (Investigators, research staff, pharmacists, laboratory staff, ethics committees)
- Participate in site identification, evaluation, contracting, initiation, monitoring and close out visits including visiting sites
- Communicate with clinical site staff, investigators and CROs to ensure optimal Sponsor-site relationships
- Monitor the timely progress of clinical studies
- Proactively manage recruitment timelines
- Suggest and implement recruitment strategies to meet study timelines and company objectives
- Proactively identify and manage potential study risks or problems
- Prepare regular updates on study progress and tracking for Management
- Assist in set-up and management of CTS
- Review sites audit reports and contribute to monitoring sites’ compliance with ICH/GCP guidelines
- Minimum 7 years of experience in clinical research with relevant experience in management of clinical phase 2–4 studies for biotech or pharmaceutical company or other sponsor
- Clinical development experience in a start-up or small-to-medium company
- Good knowledge of ICH/GCP and local regulations in USA
- Highly IT literate: MS Office with good knowledge of Word, PowerPoint, Excel, Outlook
- Complete fluency in English (written and verbal)
- Willing and able to travel within USA and occasionally in Europe
- Scientific or medical degree (e.g, Biology, Pharmacy, Clinical Research, Nursing)
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.