Title: Clinical Data Manager

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.

Please: local candidates only. This is a full-time, in-the-office role.

Overview: The Clinical Data Manager is responsible for managing the data activities for multiple clinical trials. Reporting to the Head of Biometrics in the Clinical Development function, this role will work closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and in accordance 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

What are we looking for?

· 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

What are we offering?

· 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:

· Initiate CRF development for new clinical trials and protocol amendments; collaborate with internal team and responsible vendor on CRF development, database design, and edit specifications. Ensure established clinical data standards are followed.

· Review CRO Data Management Plans, Data Review Plans, and other applicable data management documents for completeness and accuracy.

· Create internal Data Review Plans for review/approval by study team members.

· Create Data Transfer Plans for external data vendors for review/approval by study team members; perform external data reconciliations as applicable.

· Coordinate the internal data review process; perform data review periodically for quality issues and general data trends and communicate to team and/or CRO; oversee and track the ongoing delivery of clean patients by the CRO per established timelines.

· Oversee CRO data management counterparts for assigned clinical trials and ensure that the data management objectives are met in accordance with current SOPs, working practice documents (WPDs) and timelines, and budget.

· Participate in protocol review and ensure all protocol elements are accurately captured in the database taking CRF design into consideration.

· Review Statistical Analysis Plans and statistical outputs, taking CRF/database into consideration.

· Identify issues in clinical data management, propose resolutions and mitigations to the Clinical Operations team and track issues and risks through to completion

· Review/contribute to Data Management WPDs and instruction documents.

Education and Experience:

· BS/BA degree in science or a similar area; any medical degree will be a nice addition

· MUST HAVE: 3 – 5 years of prior experience managing clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management, and knowledge of 

Experience:

· 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.

· 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.

Competencies:

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

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Marengo about our openings. All resumes submitted by search firms/employment agencies to any employee at Marengo via email, the internet or in any form and/or method will be deemed the sole property of Marengo unless such search firms/employment agencies were engaged by Marengo for this position and a valid agreement with Marengo is in place. In the event a candidate who was submitted outside of the Marengo agency engagement process is hired, no fee or payment of any kind will be paid.

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.