The responsibilities of this position will be broad, and will include the support on a range of matters encompassing, but not limited to, the following:
Reviewing Clinical Operations documents such as clinical trial agreements (CTAs)
May be asked to assist in the review of informed consent forms, letters of indemnity, Confidentiality Disclosure Agreements, powers of attorney, sponsored research agreements, data privacy agreements, investigator initiated trial agreements, ancillary service agreements and other related contracts and documents.
Participating in the refinement of client's internal processes such as CTA review or other processes related to contracts and budgets
Managing various contracting responsibilities, including tracking and management of contract agreements, providing initial review and comments, liaise between CRO, legal, finance, and clinical. May help to design contract management tool.
Responsibilities may include review of site budgets, financial reconciliation during and at the end of the study, and trial budget forecasting as skills allow.
Follow-up with vendors on status of CTAs and facilitate the approval process.
Ability to lead conversations and meetings with internal and external customers with respect to the negotiation and execution of contracts and related document review.
#IND123
Qualifications
Bachelors degree or higher, preferably in Life Sciences, with at least 9+ years of relevant/clinical essential document review experience or equivalent experience.
Experience in clinical drug development process and clinical trial planning and execution practices, including IRB/ERC and Investigator Site roles and responsibilities
Knowledge and understanding of ICH/GCP and regulatory guidelines/directives, especially ICH E6 R1 and R2
Experience in Sponsor and Site related Essential Documents, including the use of CTMS for Site Creation & management, TMF, the Master Index, Sponsor vs. Site requirements
Familiarity in engaging with and supervising 3rd party service providers (CROs, Labs, etc.)
Strong and focused project management skills; Ability to effectively multi-task and prioritize in a fast-paced environment
Strong analytical skills and attention to detail; handling ambiguity; in addition to outstanding organization skills
Optimally work across the organization and with outside vendors; Ability to work in a matrix environment. Good teammate with a positive demeanor
Must possess good judgment in knowing when and how to escalate issues to the appropriate level and propose solutions.
Proficient in Microsoft Office.
Professional, proactive demeanor.
Strong interpersonal skills.
Excellent written and verbal communication skills.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Management and Manufacturing
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Accede Solutions Inc (accedesol.com) by 2x