Clinical Trial Manager
At Advanced Clinical, we’re excited to share with you a great opportunity at for the position of Clinical Trial Manager in Cambridge, Massachusetts. The Clinical Trial Manager is responsible for the management of US clinical trial(s) activities for studies under the direction of a Clinical Study Director and under supervision of the Clinical Trial and Operations Manager. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- 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 as appropriate 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 potential study risks or problems and manage them in close collaboration with cross-functional teams
- Prepare, on a regular basis, updates on study progress and tracking for the Company Management and appropriate Boards or Committees
- Participate the selection and contracting of clinical service providers
- Prepare or review and approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring reports
- Assist in set-up and management of CTS
- Maintain a competent knowledge of applicable Policies, Guidelines, Standard Operating Procedures (SOPs), conventions, tools, templates and instructions, including current Good Clinical Practice (GCP) and applicable local regulations relating to the conduct of clinical trials
- Assist in planning and managing investigator meetings, other trial specific meetings
- Manage the set-up, the organization and maintenance of clinical study documentation (Main Study Files, etc.) including final reconciliation, QC and archival of Clinical Trial Master File
- Collaborate for the payment process of external invoices and track payment of contracts related to project
- Minimum 4 years OF experience managing multisite clinical phase 2–4 studies
- Experience in coordinating or supporting the management of site-related activities, development of tracking tools, dealing with clinical sub-contractors (central laboratory, clinical and data management etc.) and ability to manage recruitment timelines by appropriate strategies
- Good understanding of the roles and responsibilities of all relevant functions involved in a clinical trial
- Good knowledge of ICH/GCP and local regulations in USA
- Good knowledge of Word, PowerPoint, Excel, Outlook
- Willing and able to travel through-out the USA and occasionally to Europe
- Complete fluency in English
- Appropriate scientific or medical degree (e.g, Biology, Pharmacy, Clinical Research)
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.