Senior Clinical Contracts Manager - Keros Therapeutics
Lexington, MA
About the Job
Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF-ß signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.
The successful candidate will partner with the clinical operations and legal teams to ensure that contracting needs are met and handled in a manner that is consistent with company requirements, applicable regulations, and good business practices. This position will report into the Sr. Director of Vendor Management.
Responsibilities:
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 Keros 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:
The successful candidate should ideally possess the following skills/attributes:
- 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.
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Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.