What are the responsibilities and job description for the Director, Clinical Data Management position at Marengo Therapeutics?
Job Type
Full-time
Description
Title: Director, Clinical Data Management
Marengo Therapeutics is pioneering first-in-class therapeutics that activate the right immune response to promote lifelong protection against cancer. Marengo has uncovered a novel approach to T cell activation by targeting the Vß TCR chain to unleash rapid, potent, and long-lasting anti-tumor immune responses safely and effectively. We’re leveraging our versatile, proprietary bispecific fusion protein platform to selectively deliver the right activation to the right T cell subsets, customizable to patient needs with its tunable properties, with an initial focus on advanced solid tumors and broad applicability beyond.
Marengo is driven by core values that guide our company’s mission and approach from the inside out: we demonstrate an unparalleled commitment to patients and their loved ones, we are confident in our science and our team, we operate with courage, and we creatively apply deep expertise to new ways of thinking with curiosity and imagination. With an exciting journey ahead and a tremendous opportunity for growth, now is the time to join the Marengo team and impact cancer patient care – are you ready to join the new frontier?
To learn more, visit marengotx.com.
Role: Director, Clinical Data Management
Please: local candidates only. This is a full-time, in-the-office role.
Overview: The Director of Clinical Data Management is responsible and accountable for the clinical data management activities in support of studies across all stages of clinical drug development. Reporting to the Head of Biometrics in the Development Organization, this role will work closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and expectations, and budget.
Who are we looking for?
Responsibilities:
Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.
Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.
Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives
changes necessary to achieve business objectives.
Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity, and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.
Location: Cambridge, MA ( We are located in Lower Cambridge, called Cambridgeport)
When You Join Marengo, You Will Have:
In addition to the compensation, we offer the following benefits:
Marengo Therapeutics, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Full-time
Description
Title: Director, Clinical Data Management
Marengo Therapeutics is pioneering first-in-class therapeutics that activate the right immune response to promote lifelong protection against cancer. Marengo has uncovered a novel approach to T cell activation by targeting the Vß TCR chain to unleash rapid, potent, and long-lasting anti-tumor immune responses safely and effectively. We’re leveraging our versatile, proprietary bispecific fusion protein platform to selectively deliver the right activation to the right T cell subsets, customizable to patient needs with its tunable properties, with an initial focus on advanced solid tumors and broad applicability beyond.
Marengo is driven by core values that guide our company’s mission and approach from the inside out: we demonstrate an unparalleled commitment to patients and their loved ones, we are confident in our science and our team, we operate with courage, and we creatively apply deep expertise to new ways of thinking with curiosity and imagination. With an exciting journey ahead and a tremendous opportunity for growth, now is the time to join the Marengo team and impact cancer patient care – are you ready to join the new frontier?
To learn more, visit marengotx.com.
Role: Director, Clinical Data Management
Please: local candidates only. This is a full-time, in-the-office role.
Overview: The Director of Clinical Data Management is responsible and accountable for the clinical data management activities in support of studies across all stages of clinical drug development. Reporting to the Head of Biometrics in the Development Organization, this role will work closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and expectations, and budget.
Who are we looking for?
- You are an energetic and passionate clinical development professional who likes to think outside of the box, challenge the norm, and is passionate about the company’s mission of discovering and developing new medications
- You are a resourceful self-starter and team player with a strong results orientation
- You consider yourself a guru in all the critical data management clinical stage organization areas
- You can develop trusting relationships to gain support and achieve results at all levels of the organization
- A driven professional who knows how to work and contribute to an ever-changing working environment
- A collegial individual who enjoys working in close collaboration with leaders in the research, development, manufacturing, quality, clinical, and administrative areas of the company
- A willingness to learn new things, adapt to new ways and go with the flow
- A person who thrives in a small company atmosphere
- Ability to determine task priority and maintain established deadlines
- Membership within a growing, CARING, and collegial organization
- Being part of a passionate, involved, and cutting-edge Clinical Development Team
- Exposure to pioneering science and the discovery of drugs to help treat patients with cancer
Responsibilities:
- Oversee and ensure the successful execution of data management activities supporting all company clinical studies in partnership with CROs, including, but not limited to, CRF development, protocol development, database build and update, data collection and cleaning, data transfer, database lock, etc.
- Develop key data management documents, workflows, and processes, including CRF development and updates, a Data Management Plan, a Data Delivery Plan, a Data Transfer Agreement, data cleaning and quality control, etc.
- Collaborate with Biostatistics, Statistical Programming, and Clinical Operations to ensure timely delivery of datasets with clearly defined quality requirements supporting data readouts for company business activities, including internal decision-making, interim analysis, publications, conference presentations, interactions with health authorities, and regulatory submissions.
- Lead the data monitoring process in partnership with internal and external stakeholders, including Clinical Operations, Clinical and Translational Sciences, Clinical Pharmacology, and Biostatistics, to proactively identify data quality issues and ensure timely data entry, query resolution, and completeness.
- Collaborate with Clinical Operations and Quality Assurance to ensure data integrity, traceability, and compliance with CDISC (CDASH, SDTM) standards and 21 CFR Part 11 standards.
- Lead Data Management-related efforts in response to audits and GCP inspections.
- Identify and evaluate novel technologies and strategies to improve data management practices to ensure the highest efficiency and effectiveness.
- Develop clinical data management visions and strategies in alignment with company goals and budget.
- BS/BA degree in science or a similar area, any medical degree will be a nice addition
- MUST HAVE: 10 years of prior experience managing clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management, and knowledge of
- Knowledge and extensive experience with data management processes and excellent oral and written communications.
- Preferred experience with oncology, particularly immune oncology.
- In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required. Experience developing SOPs, work instructions, and guidelines is preferred. Experience with NDA/BLA submissions preferred.
- Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
- Excellent organizational and priority management skills.
- Knowledge of and experience with EDC for clinical data capture. Experience with Medidata Rave is preferred.
Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.
Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.
Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives
changes necessary to achieve business objectives.
Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity, and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.
Location: Cambridge, MA ( We are located in Lower Cambridge, called Cambridgeport)
When You Join Marengo, You Will Have:
In addition to the compensation, we offer the following benefits:
- Free parking, Cambridge location reachable by public transportation (Red Line)
- Customized and competitive health coverage, including medical offered through BCBS (HMO/PPO), dental, and vision
- Flexible Spending Accounts for medical and dependent care expenses
- Eligible from the first day for 401K, no matching
- A robust package of Marengo-paid insurance coverage, including life insurance, short-term and long-term disability, and parental leave
- 20 days of vacation and one personal day, and 64 hours of sick time per year, in addition to 16 company holidays
Marengo Therapeutics, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.