Sr CRA/Clinical Trial Manager - Pharmaceutical

SUMMARY

This company is seeking an exceptional experienced Sr. Clinical Research Associate/Clinical Trial Manager to play a key role in the execution of its clinical programs. This role offers an exciting opportunity for a talented professional to contribute their clinical trial expertise as well as develop significant career experience in the emerging field of regenerative medicine. 

The Sr. Clinical Research Associate/Clinical Trial Manager is responsible for the day-to-day operations of 1-4 clinical trials commensurate with complexity including start-up, conduct, close-out activities. 

PRIMARY POSITION RESPONSIBILITIES 

• Provide the day to day operational management of CROs and/or vendors to ensure delivery against scope of work. 
• Lead the development, review and finalization of study related documents for trial execution. 
• Oversee the collation of feedback on study level documentation and ensures appropriate updates are made. 
• Collaborate with internal and external partners to facilitate operational execution of study tasks. 
• Ensure all operational tracking needs are identified to meet the needs of the team and to facilitate reporting to the study/program leader. Must be able to effectively combine data from multiple systems. 
• Provides operational input to the core study documents including the protocol, informed consent, clinical study report, and CRF. 
• Ensures accuracy of vendor invoices and site payments. Communicate variance and action to resolution to program leader. 
• Oversee forecasting and ordering of clinical/non-clinical supplies. 
• Oversee collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation. 
• Oversee external vendor data specification, reconciliation, validation and transfer to ensure data meets study analysis needs 
• Oversee clinical and vendor database migration and eCRF development as needed 
• Manage and oversee site management activities in accordance to the monitoring plan: including review monitoring reports and protocol deviations, trending errors or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required.
• Provide oversight of CRO and maintain site relationship, this can include booster visits, SIV, or KOL interactions. • Provides input into, and implementation of, the study level audit plan, quality, risk management and contingency plans. 
• Actively track progress and completion of study milestones accordingly. Ensure maintenance, tracking and reporting of operational metrics/updates. 
• Identify and participate in creation of clinical operations SOPs, best practice and standards across study team and organization as needed. 
• Monitor safety surveillance and reporting activities. 
• Organize and manages Investigator Meeting, DSMB/Safety meetings, Site/Monitoring meetings, and other study related meetings. 
• Establishes the set-up of archives for essential documents including trial master file. 
• Provide support and direction to clinical team members as assigned. 
• Ensure adherence to ICH/GCP/local regulations, and SOPs. 

QUALIFICATIONS & KEY ATTRIBUTES 

• BA/BS degree in Biological Science or Nursing required with advanced degree preferred. Potential candidates with equivalent experience and accomplishments will be considered. 
• 5+ years of clinical research experience in the biotechnology/pharmaceutical industry. Experienced with multi-center international studies is preferred. 
• Experience managing CROs, central laboratories, central imaging centers and other clinical study vendors. 
• Experience as a clinical trial monitor is a plus. Experience with surgical studies is a plus. 
• Experience preparing clinical trial timelines, budgets and contracts is a plus. 
• Knowledge of GCP and ICH guidelines, and local regulations. 
• Proficient computer skills with MS Office PowerPoint, Word, Project and Outlook is required. 
• Candidate must be proficient with advanced Excel functions VLOOKUP, IFS, COUNTIFS, Min/Max Array, Conditional Formatting by Formula and Pivot Table. 
• Ability and willingness to travel up to 15% of the time (international and domestic). 

INTERPERSONAL CHARACTERISTICS 

• Demonstrated energy and passion. A commitment to helping deliver clinical trial achievements.
• Autonomous, self-starter with sense of ownership and interest ingrowth and progress in their career via delivering results; comfortable working in a changing environment. 
• Strong interpersonal, communication and leadership skills, including the ability to build relationships both internal and external. Ability to work in an international environment with internal and/or external partners. 
• A quick study with excellent written and verbal communications and professional presentation skills and demeanor. 
• Key attributes: problem solver, creative, positive mental attitude, direct, take-charge, good sense of humor. 
• Enjoy collegial open discussions; able to thrive in the absence of egotism. 
• An outstanding work ethic, high-integrity, team player attitude.