8 Senior Clinical Contracts Manager Jobs in Lexington, MA
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Senior Clinical Contracts Manager
$123k-165k (estimate)
Contractor | IT Outsourcing & Consulting
3 Weeks Ago
Accede Solutions is Hiring a Senior Clinical Contracts Manager Near Lexington, MA
Hybrid Role
ResponsibilitiesThe responsibilities of this position will be broad, and will include the support on a range of matters encompassing, but not limited to, the following:
Qualifications
ResponsibilitiesThe 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.
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.
Job Summary
JOB TYPE
Contractor
INDUSTRY
IT Outsourcing & Consulting
SALARY
$123k-165k (estimate)
POST DATE
06/05/2024
EXPIRATION DATE
11/04/2024
WEBSITE
accedesol.com
HEADQUARTERS
INVERNESS, IL
SIZE
25 - 50
FOUNDED
2015
CEO
GARVITA SETHI
REVENUE
<$5M
INDUSTRY
IT Outsourcing & Consulting
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About Accede Solutions
Accede Solutions is a computer software company based out of Cathedral Hill, Guildford, England, United Kingdom.
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