About Orchestra BioMed

Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed is led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Orchestra’s business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by its founding team. Its flagship product candidates are BackBeat CNT for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic for the development and global commercialization of BackBeat CNT for the treatment of hypertensive patients indicated for a pacemaker and strategic partnership with Terumo for the development and global commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.

Job Summary

We are seeking a Clinical Data Manager to support our clinical data management team. In this role, you will oversee the timely and professional management of Data Management deliverables and clinical trial data, ensuring adherence to quality standards and timelines for assigned trials within Clinical Data Management. Your efforts will ensure consistently high-quality data is available for analysis and reporting.

Role and Responsibilities – Including but not limited to:

• Support the design of CRFs and other data capture tools to standardize study data collection
• Support the planning, setup, and validation of EDC and edit checks; ensure EDC capabilities are maximized
• Assisting in managing study start-up, conduct, and closeout activities
• Support the collection, review, and entry of clinical trial data into electronic data capture (EDC) systems
• Monitor data for completeness, consistency, and accuracy to maintain data integrity
• Provide continuous data review to identify errors, inconsistencies, discrepancies; track resolution in collaboration with the clinical study teams
• Ensure data is collected in compliance with Good Clinical Practice (GCP), study protocols, and company SOPs and Plans
• Assist in the preparation and maintenance of data management documentation, including data management pan, data review guidelines and data entry manuals
• Generate data reports and summaries as required for study teams and project managers
• Work closely with clinical research associates, site managers, data managers, and other cross-functional team members to facilitate smooth data management processes
• Assist in creating external data transfer agreements, ensuring alignment with SOPs and specifications to support data integration, analysis, and reporting
• Assist in validation and integration of all 3rd party data generated in clinical trials
• Assist in liaising with and reviewing work delivered by external partners (e.g., clinical research organization, core laboratories) performing services on behalf of Orchestra BioMed
• Track trial progress by reporting on enrollment status, data entry, and source document verification (SDV)
• Follow procedural documents and assist in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements and include optimal processes
• Assist in preparing for data snaps/locks for submission readiness
• Escalate issues to leadership as appropriate
• Develop and maintain working relationships with key study execution team members
• Collaborate with all levels of employees with moderate supervision required
• Participate in data review meetings and contribute to problem-solving for data issues as needed
• Other tasks may be assigned based on skillset and business needs.

Qualifications – Knowledge & Skills

Clinical Data Manager:

• Bachelor's degree in life sciences, health sciences, or a related field
• 3-5 years of experience in clinical data management is preferred
• Extensive experience with EDC systems, data -review, and basic data management principles
• Proficiency with CDISC (Clinical Data Interchange Standards Consortium) data standards
• Working knowledge of the MedDRA and WHODrug dictionary coding terms
• Excellent organizational skills and keen attention to detail
• Excellent communication skills and ability to work both independently and as part of a team
• Working knowledge of regulations, industry standards, and quality control principles
• Experience with Clinical Trial Management Systems (CTMS) and integrated Site Payment Systems will be beneficial
• Strong working knowledge of Microsoft Office

A current US work authorization is required in order to be employed with Orchestra BioMed. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.The level of this position will be based on the final candidate’s qualifications.

Why Join Orchestra BioMed

In addition to an exciting, inclusive, and collaborative work environment, Orchestra BioMed is proud to offer a comprehensive compensation package. Along with a competitive salary, including annual bonus and equity eligibility, health insurance (for employee and family), prescription drug coverage, 401(k), paid holidays, PTO & sick time, Life & AD&D insurance, disability insurance, dental, vision, pet insurance and more.

Our Vision

To be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships.

Our Mission

We will work passionately to apply our collaboration-based business model to bring high-impact medical innovations to life and create extraordinary value for patients, care providers, partners and stakeholders.

Our Values

We care about patients, physicians, partners, and each other

We are creative , open-minded, adaptable and think “outside the box”

We are driven to always do our best and we do not give up

We deliver and are accountable to promised results

EQUAL OPPORTUNITY EMPLOYER

Orchestra BioMed is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

Important notice to employment businesses/agencies

Orchestra BioMed does not accept referrals from employment agencies unless written authorization from the Orchestra BioMed Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra BioMed will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra BioMed.