Sr. Clinical Trial Specialist

ID# DCPA30813

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

POSITION SUMMARY:

This Senior Clinical Operations Specialist is responsible for managing the oversight and implementation of biomarker strategic objectives as directed by the Heme DAS Biomarker Lead. Responsibilities include budget and contract management, sample quality, timeliness and biomarker administrative needs (budget, presentations and study documents). This role is responsible for all budget and contract management related to Heme DAS biomarker related research agreements, 2 or 3 way collaborations, material transfer agreements, collaborative studies involve API, drug or data analysis, technology in licensing agreements, service agreements and consulting agreements. 

ESSENTIAL FUNCTIONS: 

  1. Assists in the procurement and development of detailed statements of work with project timelines, deliverables and payment schedules. 
  2. Assists JRP in procuring information required for contract negotiation in conjunction with project leaders. 
  3. Provides monthly updates to Senior Management 
  4. Report payables against projections 
  5. Assists in the management of the procure to-pay-process under management supervision 
  6. Ensures alignment of contract funding with business plan/Latest Thinking 
  7. Facilitation of administrative tasks related to contract negotiations (CRF submission, internal and external follow-up, signatures, purchase order generation) and ensures execution is in alignment with program timelines. 
  8. Assists business partners and external parties in the resolution of invoicing and payment issues. 
  9. Assists in procuring accrual documentation for quarter closes. 
  10.  Assists business partners in meeting requirements for capital projects. 
  11.  Ensures the timely entry of supplier information into the Aravo, Ariba and Totality systems as appropriate. 

OTHER RESPONSIBILITIES / DETAILED DUTIES: 

  1. Functions independently within an environment that relies heavily on effective communication and collaborating in a matrix. 
  2. Able to solve problems within own area of expertise. 
  3. Provides perspective and provide sample logistic information. 
  4. Provide input to the broad protocol design and review cycle. 
  5. Directs work of junior colleagues. 
  6. Represent Biomarker Community in cross-functional meetings and teams on an ad hoc basis 
  7. Display effective written and verbal communication skills. Demonstrates good judgment in what and when information/opinions are communicated. Actively seeks input, listens, and understands. Shares accurate information with peers, supervisor, or work team. Prepares reports. Delivers clear and effective presentations.. 
  8. Proactively seek to learn. Identify sources of knowledge independently to enhance personal growth. Share experience with others willingly 
  9. Clear communication skills 

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. 

PRINCIPAL RELATIONSHIPS: 

  • Contacts Inside the Company: Procurement, legal, biomarker leads, members of oncology clinical teams and CDTs, GCO and laboratory staff 
  • Contacts Outside the Company: Biomarker testing labs, Central labs, Investigators, Consultants and Opinion Leaders, Contract Research Organizations, and Vendors. 

SUPPLEMENTAL INFORMATION 

Education: 

  • Bachelor’s degree and 6-8 years industry-related experience. 

Related Experience: 

  • Strong knowledge and understanding of clinical research, ICH GCP, GLP, data management, and regulatory and legal issues related to samples. 
  • Strong understanding of shipping and clinical regulations 
  • Strong ability to write work guidance and author SOP’s. 
  • Good understanding of human physiology, pharmacology and biomarkers 
  • Functions independently within an environment that relies heavily on effective communication and collaborating in a matrix.

Position Details:

Pharmaceutical

Clinical Research

Start Date: 
4-1-2014
End Date: 
12-31-2014

SPRING HOUSE , PA

CON_W2

40

DCPA30813

No

No