Associate Clinical Trial Manager
We are currently searching for a skilled professional to join a well-known client’s team as an Associate Clinical Trial Manager (ACTM) in Cambridge, Massachusetts. The Associate Clinical Trial Manager role will be responsible for supporting the Clinical Trial Directors/Managers (CTD/CTM) in the planning, preparation, conduct, data management, biostatistics and reporting of clinical trials/programs. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Support the Clinical Operations team with ongoing conduct of studies including specific allocated study management tasks as defined by the CTD/CTMs and Clinical Trial and Operations Manager
- Set up, organize and maintain clinical study documentation (Main Study Files, etc.) including final reconciliation, QC and archiving of Clinical Trial Master File
- Support document management & organization: versioning, electronic filing, paper filing, formatting
- Track study activities in accordance with the approved study plan and timelines
- Monitor the timely progress of data entry, queries resolution and data cleaning
- Assist in set-up and management of CTS
- Review monitoring visit reports, suggest preventive or corrective actions and follow their implementation
- Collaborate for the payment process of external invoices and track payment of contracts related to project
- Perform research to support new projects or activities
- Develop and maintain a competent knowledge of applicable Policies, Guidelines, Standard Operating Procedures (SOPs), conventions, tools, templates and instructions, including ICH Good Clinical Practice (GCP) and applicable local regulations
- Provide general administrative support including internal or external meetings coordination, activities preparation, travel arrangements
- Minimum of 2 years of experience in a comparable role in the pharmaceutical industry or clinical research preferred
- Good IT literacy including Microsoft Office
- Complete fluency in English is essential (written and verbal)
- Willing to travel for job related activities
- Appropriate scientific degree or equivalent
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.