Senior Clinical Data Manager

Celldex; New Haven (CT); On-site; USD 133,579 - 173,480; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid holidays and vacation

Job summary

Celldex is seeking a Senior Clinical Data Manager in the New Haven, CT area to lead data management for multiple clinical trials. You will collaborate with internal teams and CROs to ensure trials run on time and within SOPs, ICH/GCP, and budget.

You will manage CRF development, data standards, and external data transfers, with a strong emphasis on FDA regulations and data quality. Excellent communication and multitasking skills are essential.

Qualifications

• Completed BA/BS degree in a scientific or health care field is required.
• 5+ years prior experience in clinical data management.
• Proficient in Medidata Rave; strong understanding of system configuration requirements.
• Experience with clinical data standards; knowledge of CDISC standards.
• Preferred immunology, dermatology and allergy experience.
• In-depth knowledge of data management, including FDA regulations interpretation.
• Ability to work within timelines in a fast-paced environment with multiple trials and studies.
• Excellent verbal and written communication skills.

Responsibilities

• Oversee CRO data management counterparts for assigned trials and ensure data management objectives are met.
• Initiate CRF development for new trials and amendments; collaborate on CRF design and edit specs.
• Review CRO Data Management Plans and Data Review Plans for completeness and accuracy.
• Create internal Data Review Plans and coordinate data review process.
• Review/create Data Transfer Plans for external vendors and perform data reconciliations.
• Review protocols, SAPs and statistics outputs considering CRF/Database.
• Assist in creation/review of clinical data standards and DM WPDs.

Skills

5+ years clinical data management

Medidata Rave

CDISC standards

oral and written communication

organization and multitasking

Education

BA/BS in science or health care

Tools

Microsoft Excel

Microsoft Word

Microsoft Outlook

Job description

Celldex is pioneering new horizons in immunology to deliver life‑changing therapies. We are relentless in our pursuit of novel antibody‑based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

Overview

The Senior Clinical Data Manager is responsible for managing the data management activities for multiple clinical trials. Will work closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and expectations, and budget.

Responsibilities

• Oversee CRO data management counterparts for assigned clinical trials and ensure that the data management objectives are met in accordance with current SOPs, WPDs and timelines and budget.
• 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 and coordinate the internal data review process; proficient in data review; oversee and track clean patient status.
• Review/create Data Transfer Plans for external data vendors for review/approval by study team members; perform external data reconciliations as applicable.
• Review protocols, Statistical Analysis Plans and statistical outputs taking CRF/Database into consideration.
• Assist in the creation/review of clinical data standards, DM WPDs and Instruction Documents.

Qualifications

• Completed BA/BS degree is required, with a concentration in a scientific or health care field preferred.
• 5+ years prior experience in clinical data management.
• Proficient in Medidata Rave; strong understanding of system configuration requirements and specifications.
• Experience with clinical data standards; knowledge of CDISC standards.
• Preferred experience with immunology, dermatology and allergy.
• In-depth knowledge of data management, including interpretation and implementation of FDA regulations.
• Ability to work within established timelines, in a fast‑paced environment, managing multiple clinical trials, non-study projects, and ad‑hoc assignments; lCH guidelines, and GCP is required.
• Excellent oral and written communication skills.
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
• Excellent organizational, multitasking, and priority management skills.
• Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook.

Compensation

The expected base salary range for this position is $133,579 to $173,480. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.