Associate Director, Clinical Data Management

The Associate Director of Clinical Data Management at Tango Therapeutics is responsible for overseeing the entire clinical data management process for clinical trials. This includes leading partnerships with CROs, ensuring data is accurately collected and reported, authoring key documentation, and collaborating with various stakeholders to enhance data quality and project timeliness. Essentially, the role is pivotal in ensuring that data management practices are executed flawlessly, driving impactful decisions for cancer therapies.

Applicants for the Associate Director, Clinical Data Management role at Tango Therapeutics should hold a Bachelor’s degree in computer science or a science-based subject, along with at least 8 years of clinical data management experience. Management experience in the field is crucial, ideally including oncology therapy areas. Additional experience with EDC platforms, strong vendor management skills, and an understanding of FDA and ICH GCP guidelines are also required to effectively fulfill the duties of this role.

Tango Therapeutics approaches clinical data management with a strong focus on best practices and rigorous oversight. The Associate Director will lead partnerships with CROs, develop standardized data handling plans, and create critical documentation such as database design specifications. By doing so, Tango ensures that data collected during trials remains of the highest quality and is compliant with industry standards, thereby fostering trust in the outcomes of its research.

Success in the Associate Director, Clinical Data Management role at Tango Therapeutics hinges on a combination of technical and leadership skills. Candidates should have solid technical abilities across data platforms, proficient vendor management skills, and experience with clinical trial design utilizing CDASH and SDTM standards. Additionally, strong cross-collaboration competencies with Bronstatistics and Statistical Programming teams will also be crucial to ensure data integrity and project success.

The environment at Tango Therapeutics is dynamic and fast-paced, perfect for those who thrive in collaborative settings. The Associate Director of Clinical Data Management will work closely with various teams and external partners, contributing to ongoing discussions about improving data handling and enhancing trial results. With a focus on quality and innovation, it’s an ideal place for those passionate about making an impact in the field of precision medicine.

To enhance clinical data management processes, I would initiate a review of current workflows to identify inefficiencies. I would implement standardized data handling plans in collaboration with CROs and utilize data visualization tools to streamline reporting. Regular training sessions for team members on best practices and new technology would ensure that everyone is on the same page and equipped for success.

In my previous roles, I ensured compliance with CDASH and SDTM standards by developing comprehensive data management plans that outlined processes, checks, and reviews throughout the data lifecycle. I collaborated with statistical teams for their input on standards and trained staff on the importance of maintaining those standards for data integrity and regulatory compliance.

I have extensive experience in vendor management, where I have successfully overseen outsourced data management activities from initial RFP stages to final deliverables. I maintain strong communication with vendors, ensuring that contractual obligations are met and that data quality is upheld. Additionally, I consistently evaluate vendor performance to ensure alignment with our company’s goals.

In a previous clinical trial, we encountered discrepancies in data entry across sites. I addressed this by initiating a root cause analysis involving cross-site communications, followed by revising our data entry training protocols. By implementing a real-time dashboard for data monitoring, we significantly reduced errors in subsequent phases.

To prioritize multiple projects, I implement a project management system that tracks milestones, deadlines, and resources needed. This allows me to allocate team efforts efficiently while ensuring that critical tasks are addressed promptly. Regular team check-ins help to reassess priorities and adapt to changing project needs.

I regularly utilize tools like Spotfire and other data visualization software to effectively interpret clinical trial data. These tools allow me to create intuitive dashboards that provide real-time insights and enhance communication among stakeholders. Visualizations have proven essential for identifying trends and informing decision-making.

My understanding of ICH GCP guidelines includes the principles that govern ethical and scientific quality in designing, conducting, recording, and reporting clinical trials. Adhering to these guidelines ensures that data is accurate and verifiable, protecting subject rights and ensuring the credibility of trial results.

Collaboration with cross-functional teams involves regular communication to align goals and share progress. I establish clear lines of communication with biostatisticians, clinical operations, and pharmacovigilance teams to ensure an integrated approach to data management. Workflows and responsibilities are clarified at the outset to foster a cooperative atmosphere.

I develop and standardize data collection processes by first mapping out existing workflows to identify best practices. In consultation with stakeholders, I create data collection guidelines and standard operating procedures that align with regulatory standards. Continuous feedback refreshes these processes, ensuring they remain efficient and relevant.

I stay updated on industry trends by subscribing to relevant journals, attending conferences, and participating in professional networks and webinars. Engaging with peers and staying knowledgeable about advancements in data management technology and regulatory changes helps me to effectively lead and implement best practices in my role.