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The client is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live ...

Job Description

The client is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matter and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases 

Clinical Trial Manager (CTM) 
Late Phase 

Specific Responsibilities and Skills for Position: 
- Must meet all requirements for Sr. Clinical Trial Management Associate position and have demonstrated proficiency in all relevant areas 
- Serves as the key operational contact with external investigators and internal stakeholders, for successful implementation (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs 
- Has the ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility and fair market value assessment 
- Establishes strong partnerships with external investigators and collaborators to ensure ongoing activities (e.g. sponsor updates, drug shipments, publications, milestone payments, etc) for CO and ISR studies are executed in a timely manner and with high quality 
- Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., CSM, CCF, DSPH, and Medical Affairs) to ensure efficient execution of the study management processes. 
- Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure study remains on track 
- Implements and maintains working processes to promote high quality, efficient, and compliant systems and tools for CO and ISR study management 
- Maintains a good understanding of industry standards and regulations for CO and ISR studies and keep abreast of any new changes and developments impacting Late Phase clinical operations. 
- Organizes and leads clinical operational meetings 
- Maintains internal Clinical Operations databases and document repositories 
- For GS studies, drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports 
- Must be able to understand, interpret and explain protocol requirements to others 
- Maintains study timelines 
- Coordinates review of data listings and preparation of interim/final clinical study reports 
- Assists in determining the activities to support a project’s priorities within the functional area 
- For GS studies, contributes to the development of RFPs and participates in the selection of CROs/vendors 
- For GS studies, may be asked to train CROs, vendors, investigators and study coordinators on study requirements 
- Contributes to the development of the study budget 
- May serve as a resource for others within the company for clinical trials management expertise 
- Able to examine functional issues from an organizational perspective 
- Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development 
- May contribute to the development of abstracts, presentations, and manuscripts 
- Under supervision, may design scientific communications within the company 
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision 
- Must have general, functional expertise to support SOP development and implementation 
- Travel may be required 
- Collaborates with local medical affairs colleagues on country-specific studies and initiatives 
- Provides knowledge and expertise on country-specific regulations, site experience, and suitability for development studies 

Knowledge: 
- Excellent teamwork, communication, decision-making, and organizational skills are required 
- Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies 
- Working knowledge and experience with Word, PowerPoint, and Excel 

Experience and Skills: 
-At least 5+ years of experience and a BS or BA in a relevant scientific discipline 
- At least 5+ years of experience and an RN (2 or 3-year certificate)