Senior Clinical Data Manager

About Celldex

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