Clinical Operations Lead – FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Clinical Operations Lead (COL) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. 

The COL may perform site monitoring as needed to support the flexible capacity model.

The COL is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. 

Key Accountabilities:

Trial and Site Administration:

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.

• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.

• Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations.

• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.

• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.

• Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction).

• Sets up and maintains the study in CTMS at study country level and local websites as required by local laws and regulations.

• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.

• Reviews monitoring visit reports (as required and following Client SOPs) and pro-actively advises the monitor(s) on study related matters.

• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.

• Proactively identifies risks and facilitates resolution of complex study problems and issues.

• Organizes regular Local Study Team meetings on an agenda driven basis.

• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.

• Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead.

• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.

• Develops, maintains and reviews risk management plans on country study level; proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.

• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.

• Plans and leads National Investigator meetings, in line with local codes, as required.

• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.

• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and client Procedural Documents.

• Plans and leads activities associated with audits and regulatory inspections in liaison with Clinical Quality Associate Director (CQAD) and QA.

• Provides input to process development and improvement.

• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.

• Updates Line Managers about the performance of the CRAs/CSAs.

• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.

• Collaborates with local Medical Affairs team.

• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Document Management:

• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.

• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.

• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF “Inspection Ready”.

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.

Regulatory and Site Start Up Responsibilities:

• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.

• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level.

Budgeting, Agreements and Payments:

• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).

• Ensures timely preparation of local Master Clinical Study Agreement (CSA) (including site budget) and amendments as needed.

• Ensures accurate payments related to the study are performed according to local regulations and agreements.

Compliance with Sponsor Standards:

• Ensures compliance with Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

• Ensures that study activities at country level comply with local policies and code of ethics.

• Completes timesheets accurately as required.

Compliance with Parexel Standards:

• Complies with required training curriculum.

• Completes timesheets accurately as required.

• Submits expense reports as required.

• Updates CV as required.

• Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.

Skills (Essential):

• Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.

• Excellent project management skills.

• Excellent team building and interpersonal skills.

• Excellent organizational skills.

• Excellent verbal and written communication skills.

• Excellent ability to prioritize and handle multiple tasks.

• Excellent attention to detail.

• Proficient in written and spoken English language required.

• Fluency in local language(s) required.

• Good negotiation skills.

• Good ability to learn and to adapt to work with IT systems.

Skills (Desirable):

• Good analytical skills.

• Good resource management skills.

• Good decision making and delegation skills.

• Good financial management skills.

• Basic change management skills.

• Basic coaching skills.

• Basic ability in handling crisis situations.

Knowledge and Experience (Essential):

• Extensive experience in Clinical Operations as Clinical Operations Lead, Clinical Trial Manager, or equivalent role including Lead CRA candidates has acting experience.

• Good knowledge of international guidelines ICH GCP as well as relevant local regulations.

Knowledge and Experience (Desirable):

• Good medical knowledge and ability to learn relevant Client Therapeutic Areas.

• Good knowledge of the Drug Development Process.

• Excellent understanding of the Clinical Study Process including monitoring.

• Very good understanding of the Study Drug Handling Process and the Data Management Process.

• Good intercultural awareness.

Education:

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.

Other:

• Ability to travel nationally and internationally as required.

• Integrity and high ethical standards.