Sr. Clinical Data Manager

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 110,000 - 140,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. is seeking a Sr. Clinical Data Manager to oversee global data management from study start-up to database lock and regulatory submission support.

You will coordinate with CROs, internal statisticians, and vendors to define data requirements and ensure data quality across trials. Ideal candidates have a minimum of five years in data management, strong Medidata Rave experience, and familiarity with Phase I–III global studies.

Qualifications

• Bachelor’s degree in biological sciences, biometrics, mathematics, or related field.
• Minimum of 5 years DM experience with at least two years at a Sponsor company.
• Experience with Medidata Rave EDC software.
• Experience with Phase I–III trials, preferably global.

Responsibilities

• Develop and own data management processes from study start-up to database lock and regulatory submission support.
• Coordinate with CROs, internal BioStats, vendors, and trial operations to define data management requirements.
• Lead data cleaning, query issuance, and data listings for laboratory and database data.
• Ensure readiness of SOPS, eCRFs, and DMPs to meet study requirements and updates as needed.
• Collaborate with DM CROs to reconcile data across vendors and ensure timely data entry and quality.

Skills

Clinical Data Management

Medidata Rave

Global trials

Communication skills

Project coordination

Education

Bachelor’s degree in biological sciences or related field

Tools

Medidata Rave EDC

Job description

COMPANY

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.

JOB SUMMARY

The Sr. Clinical Data Manager is responsible for developing and managing all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support. This position coordinates activities with the DM Contract Research Organization (CRO), internal and external BioStats, laboratory vendors, database programming and trial operations to define and implement data management requirements.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Ability to develop and own processes related to data compilation, tracking, maintenance, cleaning, and finalization including the ability to develop, run, review, and maintain data listings for laboratory and database data.
• Proactively identifies risks and flags findings during ongoing study to clinical management and may develop materials and present to CRAs, sites to ensure consistent, quality data capture.
• Facilitates and leads all data cleaning including issuing queries along with guidance on issuance and acceptable closure of queries on an ongoing basis.
• Demonstrates a strong understanding of the assigned study protocol(s), critical tasks, and associated milestones.
• Ensures completeness, correctness and consistency of routine clinical data and its structure.
• Work closely with DM CRO to ensure weekly reconciliation with multiple vendors for timely and quality data entry, lab completion and resulting, and eDiary data entry and compliance.
• Work closely with DM CRO to ensure all eCRFs, CCGs, Edit Checks, SOPs and DMPs meet study requirements and assist with updates as required.
• Assistance with any required updates to the Medidata Rave EDC system and associated UAT, and updated documentation.
• Works collaboratively with both internal team members and associated CROs / vendors to meet project deliverables and timelines for clinical data acquisition, quality review, clinical study reports, documents required for regulatory submission and assistance as needed.
• Close collaboration with Stats and Clinical teams to manage frequent DMC meetings including timeline development, data cleaning, management of EDC and lab data transfers, and more.
• Aid study manager in managing and tracking database interim review and lock timelines and ensure CDM project milestones are met in coordination with the project team.
• Develop and maintain relevant report metrics to share with overall study team and upper management. The ability to note and monitor trends across regions will be key.
• Ability to support the clinical team with additional ad-hoc tasks such as newsletter preparation, CRA training.
• Support study-level audit and inspection readiness activities, as needed.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS

• Bachelor’s degree, with a focus in biological sciences, biometrics, mathematics, etc., or equivalent combination of experience and education.
• Minimum of 5 years DM experience with at least two years at a Sponsor company.
• Experience and familiarity with Medidata Rave EDC software.
• Experience and familiarity with Phase I, 2 and 3 trials, preferably global.
• Experience and familiarity with interim analyses and freezing and locking databases.
• Excellent communication and time management skills, including collaboration across functional disciplines.
• Ability to prioritize study load and associated tasks.
• Chosen candidate must be autonomous, independent and must take initiative to manage, own, and lead all aspects of DM while contributing to overall study team.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.

Passionate. Smart. Motivated. We’re all these qualities—but most importantly, we’re committed to making a difference in the lives of those living with hereditary angioedema (HAE) and other rare diseases. If you’re someone who turns challenges into triumphs and aims to achieve beyond what you think is possible, we’re waiting for you. Culture is the fabric that binds us together and makes our company a special place to work. We are powered by our people, and every employee can provide valuable input on how we can achieve our goals through a culture of accountability. Our bold thinking comes from our “people-first” perspective, where we are united across fronts to do the right thing for patients, without fear of failure—but with embracing the learnings gleaned from setbacks that fuel our self-awareness. We value ownership, integrity, and the ability to laugh and learn from our mistakes. We are proud of our ability to reward innovative thinking and grow from personal and professional discovery.